Support in country Quality and Compliance

  • Location: Zaventem
  • Job #22770

Support in country Quality and Compliance

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

Scope of work:

  • Country Quality Management
  • Develop, implement and maintain the local Quality Management Systems (procedures).
  • Applying Quality Risk Management (QRM) principles.
  • Formal management review meetings (business and regional Quality Management).
  • Management of audits and inspections of the local office (e.g. HA, Corporate).
  • Self-Inspection planning, execution, documentation and communication.
  • Prepare / Review / Approve Responses / Corrective and Preventive Actions (CAPAs).
  • Ensure that initial and continuous training programs are implemented and maintained, including assessment of training effectiveness.
  • Complete trainings as required for role.
  • Ensure Quality-related tasks are included in job descriptions for relevant personnel.
  • Development and keeping of records for any delegated duties.
  • Ensure quality and accuracy of documentation and records retention.
  • Approve and review local procedures with Quality impact.
  • Tracking, trending or signaling of PQCs.
  • Handling and routing of suspect Counterfeit, Diversion or Tampering (CDT) notifications.
  • Coordination of Customer Temperature excursion assessment.
  • Deviation management, overview and tracking.
  • Management of CAPAs, including tracking.
  • Ensure handling of temperature excursions during transport, warehousing and distribution.
  • Ensure Change Control procedure is applied.
  • Computerized systems with quality impact
  • Ensure only validated IT-systems are used in the GxP area.
  • Establish and maintain local overview of used IT-systems with Quality-impact.
  • For local IT-systems, ensure Back-up and Disaster Recovery plan exists.
  • Ensure customers and suppliers have the appropriate HA authorization to manufacture, warehouse, distribute, or purchase medicinal products.
  • Ensure transactions are monitored for detection of unusual sales patterns and initiate deviation procedure including HA notification as needed.
  • Participate or ensure due diligence and audits to assess competence and reliability of external partner(s).
  • Review and approve Quality Agreements to ensure inclusion of appropriate Quality elements partner(s).
  • Approval of any subcontracted activities which may have impact on GDP.
  • Quality oversight of subcontractors and Third-Party Logistics provider (3PL) to ensure operations (e.g. incoming inspection of MSD products, storage, picking and distribution) complies with regulatory requirements and the conditions specified in the Dossier.
  • Compliance monitoring (e.g. Visits, meetings, metrics reviews).
  • Decide on the final disposition of returned, rejected, recalled or falsified products independent from commercial functions or management.
  • Approve any returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to (e.g. MIF for immunological products).
  • Control of incoming goods arrangements.
  • Ensure or Monitor accuracy of delivery documentation (e.g. Batch Release Certificates).
  • Warehousing and inventory management
  • Ensure correct storage conditions are applied and monitored.
  • Returned Goods Management
  • Approve deviations from First Expiry First Out (FEFO) principle.
  • Issue or respond to Administrative Holds (Quarantine Management).
  • Local Destruction oversight.
  • Ensure end-to-end knowledge of transportation conditions from manufacturing site to customer.
  • Ensure adherence to product storage conditions and special conditions.
  • Ensure qualified equipment and packaging is used for temperature-sensitive products.
  • Ensure handling of complaints related to distribution.
  • Management of repackaging/re-stickering activities in coordination with MM.
  • Oversight of repackaging/re-stickering activities.
  • Metrics / Regulatory Compliance
  • Ensure preparation of Quality Metrics (e.g. deviations, inspection outcomes, PQCs, CAPAs).
  • Present Quality Metrics to stakeholders (e.g. management, Quality Compliance Council).
  • Oversee and Track Quality Improvement Actions.

 

 

Profile:

  • You have a master’s degree in Life Sciences.
  • You have experience in Quality Assurance at least of 2 years.
  • You have a good knowledge of Good Distribution Practice.
  • You have a good knowledge of the operation of the Supply Chain.
  • You have great English skills, a good knowledge of French and notions of Dutch.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

 

Are you interested? Apply now!

Support Operations Manager

  • Location: Zaventem
  • Job #22727

Support Operations Manager

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Takkenpakket:
 

  • Leiding geven aan een team van operatoren en ervoor zorgen dat de productie efficiënt, veilig en kwaliteitsvol verloopt rekening houdend met de procedures geldend in de pharmaceutische industrie.
  • Organiseren en opvolgen van het team van operatoren op basis van de productieplanning;
  • Verantwoordelijk voor een efficiënte en effectieve werkvoorbereiding;
  • Instaan voor de optimale kwaliteit van de geleverde producten;
  •  Opstellen, uitvoeren, en evalueren van verbeteringsdoelen.

     

Profiel:

 

  • Hogere opleiding in een wetenschappelijk omgeving;
  • Ervaring in een gereguleerde productieomgeving ;
  • Gedreven persoonlijkheid met interesse in techniek
  •  Aangeboren zin voor complexiteit en een affiniteit om verbeteringen aan te brengen.
  • Empatisch
  • Je bent bereid de vroege en late ploeg te doen

 

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer!

Support Medical Information Officer

  • Location: Zaventem
  • Job #22655

Support Medical Information Officer

Brussels – Contracting

Our partner is looking for a Support Medical Information Officer to join its teams. This international company is well known for its pharmaceutical products.

Your responsibilities?

  • Responds in first line to all unsolicited on-label and off-label inquiries received from healthcare providers and the public.
  •  Responsible for research, assessing and compiling high-quality timely responses in a fair and balanced accurate format by relevant searching of literature to create clinical support for the products
  • Records details of such inquiries in a database according to global and local processes and creates and maintains related medical response letters
  • Provides the Medical Director with an update on relevant product issues
  • May participate in cross-function task forces/brand teams on an ad hoc basis
  • Provides training related to Medical Information processes to the relevant stakeholders and newcomers.
  • Provides Medical Information support (literature search, synopses etc) for other internal customers (marketing, medical affairs, external affairs) Medical Review
  • The MIO is an active team member for the Medical and Legal Review Process of promotional materials.
  •  Ensures full compliance according to Belgian rules and regulations as well as MSD worldwide review guidelines.
  • The MIO can be asked to provide medical training of internal stakeholders (marketing and sales) if additional support is required by the MAM/MSL or if there is no MAM/MSL available DPOC
  •  The MIO is an active team member within the DPOC function and handles incoming medical information requests, adverse events and product quality complaints.
  •  Reports adverse events to the Drug Safety Department and handles Product Quality Complaints within the established timeframes

 

Your profile?

  • The position requires either a Master in life science or other relevant degree (e.g. para-medical diploma) unless relevant proven prior experience in this type of function.
    SkillsMedical/scientific orientation
  •  Knowledge of diseases and drug therapies especially related to MSD products
  • High level of scientific and ethical integrity
  •  Excellent team player
  • Excellent presentation skills
  • Excellent understanding of core systems, tools, and metrics included but not limited to medical literature software
  • Trilingual

 

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

Support in Lab/Analysis OSD

  • Location: Zaventem
  • Job #21412

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Support in Lab/Analysis OSD

Verantwoordelijkheden:
 

  • Uitvoeren en evalueren van analytische tests (voornamelijk HPLC, dissoluties, pH en TLC) op tabletten volgens bedrijfsprocedures en -normen;
  •  Review van uitgevoerde testen;
  • Duidelijk, volledig en correct invoeren van de resultaten in het LIMS systeem;
  • Initiëren van afwijkingsrapporten, initiëren van "Out Of Trend" of "Out Of Spec" onderzoek indien nodig en rapporteren van de bevindingen;
  •  Beoordelen van testresultaten van collega's (Analysten);
  • Melden en rapporteren van resultaten, die niet binnen de specificaties vallen, aan de Senior Analyst/Supervisor;
  • Verantwoordelijk voor deelname aan deviatie-onderzoeken.
     

Profiel:

  • Bachelordiploma in een chemische, scheikundige of andere relevante wetenschappelijke richting;
  • Ervaring in een soortgelijke laboratoriumfunctie is welkom
  •  Kennis van analytische technieken;
  •  Kennis van algemene softwaretoepassingen (Word, Excel, Outlook);
  •  In staat om zelfstandig te werken en eigen werk te plannen;
  •  Sterke teamgeest, verantwoordelijkheidsgevoel, integriteit en betrouwbaar;
  • Doorzettingsvermogen en nauwkeurigheid;
  • Goede mondelinge en schriftelijke communicatieve vaardigheden in het Nederlands (must) en Engels (pre);
  • Shift regime: Week dag – week vroege – week dag – week late

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!

Expert RA in animal health

  • Location: Zaventem
  • Job #22329

Expert in RA Animal Health

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

 

Scope of work:

  • Building and maintaining the necessary knowledge in the area of law and legislation, especially concerning veterinary medicinal products (VMPs).
  • Acting as a source of information for internal MSD employees regarding RA topics and law and legislation.
  • Participating in general RA, marketing and animal species meetings to be aware of marketing and sales activities on the one hand and to bring forward relevant RA topics on the other hand.
  •  Investigating possibilities for changing national registration of products at the request of the commercial Business Unit (BU).
  • Keeping up to date with scientific and other relevant developments by attending congresses and symposia.
  • Helping and guiding other RAMs, Sr. Regulatory Affairs Associates (RAAs) and PV Managers (PVMs), e.g. in a specific area of expertise and experience.
  • Fulfilling the role of first point of contact for a specific area of expertise for the internal MSD organization (BUs) and for external organizations.
  • Following MSD AH global procedures and write/review local RA-procedures whenever this is needed.
  • Advising the MSD RA Associate Director in a specific area of expertise.

    • Regulatory tasks:
    The RAM is responsible for controlling a group of MSD AH VMPs. This concerns the following tasks:
    – Obtaining and changing of product registrations obtained through the National Procedure (NP). These activities are carried out independently, often after initiation by MSD AH Global RA (GRA), but sometimes also by MSD AH Benelux.
    – Obtaining and changing of product registrations obtained through the Mutual Recognition Procedure (MRP) or the Decentralized Procedure (DCP). These activities are carried out after initiation by GRA.
    – Supporting the obtaining and changing of product registrations obtained through the Centralized Procedure (CP). These activities are carried out after initiation by GRA.
    – Obtaining and changing of product registrations that are kept for Free Sales Certificates (FSCs) for MSD AH Global.
    – This life cycle management involves translation of product information texts and taking care of other country-specific aspects of the RA process.
    These tasks involve collaboration with MSD RA employees from Global RA and consultation with the aCBG-BD, FAGG and Luxemburg authorities.

  • The RAM is responsible for RA data in the IRIS system. This concerns the following tasks
    •  Entering RA data in case of new products.
    • Entering RA data in case of new presentations of an existing product.
  •  Packaging tasks:
    • Starting new packaging items (package leaflet, label and box).
    • Starting the change of existing packaging items.
    • Checking and approving packaging items.
    • Communication about packaging issues with Global labeling
    • Communication about packaging changes with the BU.
    • Entering regulatory data in the IRIS system in case of new products or new presentations of an existing product.
    • Communication with logistics to see when new packaging items are actually used for new batches of product.
  • Promotional tasks:
    • Checking promotional items in the Veeva Promomats system.
    • Advising in the preparation of promotional items when requested.
    • Advising in the reaction on promotional items from other VMP companies.
    • Helping the BU with their argumentation in case of a formal case with another VMP company.
    • Train employees in the local procedure

 

Profile:

  • Bachelor or Master degree in Life Sciences (Biology, Medical Biology, Life Sciences, Veterinary Science, Chemistry, Pharmacy, etc.)
  • Knowledge and experience (1-5 years) in the area of RA, preferably of veterinary medicines
  • Strong analytical capabilities
  • Strong working area exceeding capabilities
  • Stress resistant and firm
  • Result driven
  • Compliance and quality driven
  • An accurate and systematical way of working
  • Pragmatic and flexible, team player
  • Excellent speaking and writing capabilities of the Dutch and English language
  • Good writing capabilities of the French and German language
     

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

 

Are you interested? Apply now!

 

Validation Expert Analytical Lab

  • Location: Zaventem
  • Job #22101

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

Validation Expert Analytical Lab

Scope of work:

 

Areas of responsibilities are:

  • Validation of analytical methods & method transfer:
    • need to be able to set up and write a validation protocol.
    •  to analyze the validation results
    • provide conclusion.
    •  write validation report.
  •  Cleaning Validation:
    • Sample preparation
    • HPLC analysis
    • Processing of HPLC data with Empower software.
  • Compendial review:
    • Assess compendial changes,
    • perform method verification.
    •  training of analysts
  • Annual review (reduced testing program):
    • Data analysis + reporting
  • Response to internal & external enquiries
  • Review data generated by other analysts of the team.
  • Develop and/or review departmental documentation including lab data sheets, training documentation, SOP's, change controls, deviations and CAPA (Corrective Action/Preventive Action) ensuring compliance with GMP and applicable regulatory guidelines.
  • Provide analytical technical expertise in pharmacopeia tests, regulatory requirements, changes, and investigations, root cause analysis.
  • Share successes with other departments during report out session with management
  • Organize and lead method transfer project meetings, attend conference calls.
  • Attend daily communication.
  • Work according to applicable safety guidelines.

 

 

Profile:

  • You hold a master’s or bachelor’s degree in chemistry/sciences/pharmaceutics or equivalent by experience.
  • You have minimum of 2 years’ experience in an Analytical Lab.
  • You have xperience in the creation of validation protocols, SOP’s, and preparation of validation reports.
  • You have xperience with HPLC (experience on Waters system is a plus) • Knowledge of Pharmacopeias (USP, Ph. Eur., JP)
  • You have working knowledge of cGMP requirements.
  • You have good verbal and written communication skills.
  • You are able to work precisely and accurately.
  • You are a team player with ability to work independently and to work in global cross-functional project teams.
  • You have a proactive attitude, taking initiative to help drive the projects forward.
  • You have strong organizational skills and demonstrated ability to manage projects to completion are highly desired.
  • You have strong demonstration of problem-solving skills.
  • You are open for innovation and proposal of new ideas.
  • You have good creativity thinking skills.
  • You are able to understand and extract necessary information from technical documents.
  • You are able to effectively manage workload and prioritize activities. Ability to handle multiple tasks simultaneously and to meet critical milestones and goals.
  • You have strong computer skills, including experience using Microsoft Word, Excel, PowerPoint.
  • You have good knowledge of Dutch and English language

 

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

 

Are you interested? Apply now!

Support CTA/CTC for ESD Studies

  • Location: Zaventem
  • Job #21298

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us! Support

Support CTA/CTC for ESD Studies

Scope of work:

ESD studies assistant tasks:

 

  • Assemble and provide support for timely Clinical Trial Submissions and availability of
    Essential Documents for clinical trials.
  •  Create Essential Documents Repository.
  • Assemble and track availability of all essential documentation required for study
    conduct.
  • Provide professional presentation of study materials for investigator/vendor or country
    operations meetings
  • Liaise with sites and in house departments to ensure appropriate regulatory follow-up
  • Organization and documentation (minutes) of project team meetings where need be
  • Operational and project support activities, including, but not limited to:
  • Update, maintain and monitor CTMS to allow accurate project management,
    regulatory reporting and clinical grants payments
  • Follow-up/check final accountability of IMP and return or destruction as appropriate
  • Possibility for SME roles: CTMS, TMF steward, SIP, CLMS, Safety reporting tracking

 

Support of clinical grants tasks:
 

  • Review study budgets/clinical trial agreements for consistency with study protocol
  • Updating of clinical and study planning databases
  • Review study budgets/clinical trial agreements for consistency with study protocol
    • ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows, tracking, renewals) + troubleshooting with compliance, technical services etc.
  • Clinical trial payments and payment tracking
    •  Financial disclosure (check need, track, process letters and documentation)
    •  Denied parties screening (DPS)
  • Compliance checks
  • Disclosure agreements: Generate and track Trial master file reconciliation of clinical grants/compliance documents
  • Maintenance of trackers
    • GMS (grants management system): enter and track payments, run reports execute payments in COMET (SAP), purchase orders as needed

Profile:

 

  • Bachelor’s degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field
  • Advanced computer skills: e.g. professional using of MS Office programs for daily business : Excel. Candidate must be able to build quick basic understanding of SAP COMET, Grants Management System and eTMF (VAULT)
  • Advanced communication skills (written and verbal) in local languages and English
  • Understanding and knowledge of study protocols and study working documents, lab manuals, etc
  • Good understanding of the clinical research processes
  • Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations

 

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

 

Are you interested? Apply now!

Support in Microbiological Lab analysis/testing and review

  • Location: Zaventem
  • Job #21214

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Support in Microbiological Lab analysis/testing and review

Scope of work:

  • uitvoeren en nauwkeurig documenteren van microbiologische labo analyses (endotoxine testen, biologische assays, viable counts, ….)
  • uitvoeren van allerlei ondersteunende labo aktiviteiten (maken van voedingsbodems, stocks aanvullen, reinigingsaktiviteiten, …)
  • review van labo analyses van collega’s
  • shiften : 1 week vroege – 1 week late – 1 week dagshift
  • context is het recentelijk en onvoorzien wegvallen van capaciteit in het Labo Microbiologie die zo snel mogelijk dient aangevuld te worden, structureel maar concreet ook om de zomerplanning te ondersteunen.

Profile:

  •  Wetenschappelijke bachelor als minimum, bij voorkeur werden laboratoriumtechnieken gecovered
  •  Concrete labo-ervaring is een plus maar ook schoolverlaters welkom
  •  Nauwgezet, ordelijk en gedisciplineerd (microbiologische) analyses uitvoeren en documenteren volgens standaardprocedures
  •  Goede communicatie-skills vb. wanneer iets fout liep, rond planningsachterstand, equipment-problemen, afspraken maken met andere collega’s
  •  Goede teamplayer skills : niet enkel in het belang van je eigen werk denken maar denken als groep en hoe we mekaar kunnen helpen waar nodig

     

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!

 

Support in analytical analysis

  • Location: Zaventem
  • Job #21941

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

Support in analytical analysis

Scope of work:
 

  • Execute and evaluate analytical tests (on raw materials/semi-finished products
    (bulk)/finished products according to pharmacopoeia and Schering procedures and
    standards. Perform all tests based on Heist testing quality monographs and in accordance
    with SOPs.
  • Sample, test and evaluate water controls of city-water, DI-water, WFI and clean steam.
  • Write the analyses reports.
  • Enter the results of the tests clearly, completely and correctly into the LIMS system.
  • Initiate deviation reports, initiate « Out Of Trend » or « Out Of Spec » investigation as needed and report the findings.
  • Review test results conducted by someone else.
  •  Results that are not within specifications must be reported to the Senior Analyst/Supervisor immediately
  • Perform all lab activities according to cGMP guidelines.
  • Read and handle pharmacopoeia and standards
  • Write and update SOP’s
  • Perform calibrations of balances and glassware and other small instruments.
  •  Daily review of the temperature and humidity registrations of equipment.
  •  Propose new or adapted equipment and instruments for the laboratory.
  • Follow-up delivery of Certificates from the suppliers
  • Follow-up the stock of all lab material needed
  • Assure that expired materials are destroyed and inventory list is update

 

Profile:

 

  • Bachelor’s degree in science and/or preferably experience of 2 years or more in a similar
    lab.
  • Knowledge of ANALYTICAL techniques.
  • Knowledge of general software applications (Word, Excel, Outlook,…
  •  Active/good knowledge of English and Dutch
  • Passive knowledge/ notions of French
  • Being able to work independently
  • Good communication skills
  • Team spirit
  • Sense of responsibility
  • Problem solving skills
  • Accuracy
  • Planning of own work
     

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

Are you interested? Apply now!

 

 

Master Data Process Engineer

  • Location: Zaventem
  • Job #21766

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Master Data Process Engineer

 

Takkenpakket:

  • Initiëren van “changes” in het global change management systeem (~database waarin wijzigingen worden opgevolgd), gerelateerd aan “end of lifecycle” SAP itemnummers en/of families om de betrokken afdelingen te ondersteunen en de geldende locale, regionale en globale richtlijnen te volgen
    • Evalueren van de impact van voorgestelde wijzigingen op de voor de site geldende processen en systemen
    •  Erop toezien dat alle relevante informatie tijdig wordt verzameld, in samenspraak met alle betrokken stakeholders
  •  Documenteren van de status van de projecten (van start to einde) waaraan wordt gewerkt: in dialoog blijven met de betrokken interne departementen/stakeholders met betrekking tot de status; oplossen/troubleshooten van problemen indien deze aan de horizon opduiken.
  •  SAP Material Masters: opzetten van nieuwe codes en SKU life cycle management optimaliseren
    • Coördinatie tussen MES-team, Print Coördinatoren en IPTs: verzamelen van de nodige input om tot een goed resultaat te komen.
    •  Aanpassen van lokaal beheerde material master Velden
    •  Respecteren van de geldende afspraken m.b.t. doorlooptijden
  • Gebruiken van de aangereikte tools om proactief en in overleg met de betrokken partijen de kwaliteit/conformiteit van de master data te verbeteren; toepassen van de “best practices
  • Tickets in BPM tool (Business Process Management tool, software om master data wijzigingen te initiëren/op te volgen/goed te keuren (Appian) ): coördineren (verzamelen van nodige info), indienen en opvolgen
  •  Downloaden en analyseren van data; support bieden bij het opzetten/onderhouden/opvolgen van metrics
  • Uitvoeren van root cause analyses bij master data problemen in samenspraak met collega’s en andere SMEs; voorstellen tot efficiëntieverbeteringen formuleren
  • Operationeel opvolgen van serialisatie- en aggregatiebehoeften en deze tijdig verwerken in de softwaresystemen die hiervoor werden opgezet

 

 

Profiel:

  • Bachelor/ Master diploma (vb Industrieel Ingenieur / Toegepaste Economische Wetenschappen/ Bio-ingenieur).
  •  Uitgebreide kennis van alle Microsoft Office programma’s (vooral Excel)
  • Bij voorkeur overweg kunnen met SAP of een ander ERP-systeem en enige relevante werkervaring met master data verwerking is gewenst
  •  Je hebt een passie voor data
  •  Je kan gelijktijdig werken aan verschillende projecten en werkt proces geörienteerd
  •  Je beschikt over sterke analytische en organisatorische vaardigheden; nauwkeurigheid primeert boven snelheid
  •  Je bent flexibel ingesteld om wijzigingen op een snelle manier te verwerken
  • Je bezit sterke organisatorische eigenschappen
  •  Je toont gedrevenheid om de business te begrijpen, om zo master data en/of SAP set-up te beheren, in overeenstemming met de businessnoden en initieert efficiëntieverbeteringen waar nodig
  •  Je werkt nauwkeurig en accuraat: je hebt oog voor detail
  •  Je beschikt over uitstekende analytische en probleemoplossende vaardigheden
  •  Je neemt initiatief, je hebt een positieve mindset en je kunt autonoom werken
  •  Je stelt de juiste prioriteiten, met het oog op de voorziene deadlines
  • Je bent een vlotte communicator met de nodige empathie waardoor je teams weet te enthousiasmeren voor changeprojecten.
  • Je kan je vlot uitdrukken in het Engels, zowel mondeling als schriftelijk

 

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!