Opvolgen, reviewen (en behandelen) van QA events gerelateerd aan Materialen en Services
Opstarten, reviewen van CAPA's
Opstellen en reviewen van nieuwe/bestaande procedures, materiaal specificaties
Quality ondersteuning bieden bij wijzigingen (change control)
Quality ondersteuning bieden bij Materiaal/supplier kwalificatie activiteiten (nieuwe en bestaande materialen en services)
Quality ondersteuning en opvolging van GMP onderzoeken, alsook ondersteuning bieden bij opstart van nieuwe projecten
Deelnemen aan interne audits en inspecties Organiseren en uitvoeren rondgangen in de magazijnlocaties
Wie ben je?
Bachelor of Master in een wetenschappelijke richting of gelijkwaardig door ervaring
Grondige kennis en interpretatie van cGLP/cGMP/cGCPs in een gereguleerde omgeving
Uitmuntende nauwkeurigheid en oog voor detail
Teamplayer
Goede writing skills
Goede kennis van de Engelse taal
Wat kan je verwachten? Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.
Construction Manager Brabant Walloon – contracting Our partner is looking for a Construction Manager to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities?
Coordinate construction activities and liaise with the Host Site EHS team
Review safe methods of working ahead of work starting
Lead daily safe work planning sessions e.g. SPA, RAMS, PTW
Participate in daily prestart workforce safety briefings
Participate in safety meetings and lead daily safety walks of the site
Participate in toolbox talks
Assist in incident investigation
Induct / orientate the workers
Identify and control new workers
Identify general and specific safety hazards to the workers
Inspect and conduct safety audits of tasks and safe systems / processes
Ensure that all incidents are reported
Participate in incident investigations
Ensure workers only carry out tasks for which they are trained and qualified
Ensure risk assessments and method statements are in place and in use
Encourage and participate in the behavioral safety system
Intervene and correct any unsafe conditions
Participate in safety meetings
Ensure good housekeeping and organised tidiness (5S) at all times
Your profile?
Experience in construction management of medium and large capital projects
EHS experience
Project and people management skills with thorough knowledge of construction
Communication and collaboration skills
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner for each step along the way.
Validation Engineer Brabant Walloon – contracting Our partner is looking for a Validation Engineer to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities? The department is, amongst other expertise, in charge of the implementation of health authorities Facility Design requirement for all manufacturing building in the Belgium sites. A new task is required : implementing internal standards of the company (Engineering Standard) You will be responsible for leading the implementation of this new standard in several steps :
Gap analysis between Engineering Standard and Belgium SOP’s
Support and lead risk assessment issuing for each unit with local SMEs
Follow up and track progress on assessment issuing as per milestone.
Participating in the assessment to standardize inter manufacturing units evidences and assessment (same answer for requirement, adding and suggest control or mitigations, identifying gaps).
Possibly, support the Unit to edit remediation plans for gaps identified.
Furthermore, the candidate leads the reporting to Engineering Standard Duty holder and sponsor.
Your profile?
Scientific university degree (Engineer in Chemistry, biochemistry, or Pharmacist,…)
Experience in Product & Process
Experience in project management
Risk assessment
Successful experience in stakeholders management
Excellent organization skills and ability to operate effectively in a multicultural, matrix organization where the workload requires balancing multiple responsibilities simultaneously
Fluent in French et English
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]
Your responsibilities: Commissioning and Qualification: Review IQOQ protocols and reports to ensure the qualification of CPP, support the team for risk analysis creation (SRA), review equivalence certificate, write validation plans…
Validation: According to the client’s standards and procedures, design the validation strategy through PQ protocol redaction, ensure the readiness for PQ validation, coordinate validation (on the floor job expected), manage unplanned events associated with validation, be the contact with QC.
Product validation: Understand the product validation lifecycle and ensure that the validation strategy is in line with the product validation strategy, support the product steward in product related topic (E&L, holding time, …).
Change Control: Assessment of the validation impact through eCC assessment (Stakeholder role expected), Coordinate eCC, and be responsible of eCC tasks.
Project management: Plan and manage PQ activities (material, documentation, people…), support the project planner, animation of meetings/workshops, help the production representative in the understanding of validation requirements.
Your profile:
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy).
At least 5 years’ professional experience in pharmaceutical environment, in quality and validation environment.
Good oral and written communication skills in French & English (for efficient communication with engineering office and suppliers).
Good Knowledge of GMP Regulated environment related to validation activities.
Good interpersonal relationship skills – To be a good team player to success in each validation.
Problem solving and achievement oriented.
Be organized.
Nice to have:
Knowledge of freezer dryers, filling lines and isolators would be an asset.
To maintain and keep up to date its knowledge and experience necessary to the function.
Ability to take decisions in stressful conditions.
Proactive and ready to take the lead to make things happen.
Ability to work under pressure on multiple deliverables within project timelines.
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. Are you interested in this job? I kindly invite you to apply or send me your CV, [email protected]
Product Quality as the independent quality authority for product-related qualifications and validations of the assigned products.
Compliant and right first-time product launches within Quality Operations (QO)
Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings
Validation Act as quality authority in a consistent way, in compliance with cGMPs and current regulatory expectations, for the following qualification and validation documents:
Process qualification/validation
Method validation
Filter validation
Component qualification
Raw material evaluation
DHF
Registration The composition, production processes, specifications, analytical methods of the drug products are described in the registration dossiers of the different markets. The QPA is responsible for pursuing regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved by participating in the following processes:
Data verification and QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings;
Performing compliance checks of the registration dossiers of the different markets versus the site practice.
Implementation Ensure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets.
Your profile:
Master’s degree in scientific discipline
2 years of relevant experience in the pharmaceutical sector and/or medical device industry with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for pharmaceutical products.
Quality mindset
Pragmatic
Excellent analytical and problem-solving skills
Excellent oral and written communication skills and social skills
Scientific knowledge and skills
Languages: fluent in Dutch and English
Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.
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. Are you interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Ontwikkelen, implementeren en uitvoeren van URS, SIA, DQ, IQ, OQ, PQ, RV en TM activiteiten voor kleinschalige apparatuur, inclusief de bijhorende software.
Opzetten en uitvoeren van validatiestudies voor cGMP-kritische processystemen om compliance met cGMP, gebruikers- en regelgevingsvereisten aan te tonen.
Uitvoeren van kwalificaties van systemen waar industriestandaarden bestaan maar interpretatie vereist is, conform cGMP, cGLP’s en Sanofi-procedures.
Zorgen dat de gekwalificeerde status van systemen steeds cGMP-conform blijft.
Ondersteunen van projecten in lijn met cGMP-regelgevingsnormen.
Op de hoogte blijven van nieuwe validatieregels en testpraktijken, en technische ondersteuning bieden m.b.t. FDA- en EU-vereisten.
Beheren van validatiedocumentatie van opmaak tot goedkeuring en implementatie.
Input leveren bij change assessments om te bepalen of wijzigingen impact hebben op de gekwalificeerde status en documentatie.
Profiel
Grondige kennis van cGMP-vereisten in een gereguleerde omgeving.
Begrip van relevante kwaliteits- en compliance-regelgeving.
Probleemoplossend en in staat om validatie-issues te troubleshooten.
Goede kennis van Quality Management Systems.
Ervaring: 2–4 jaar in een farmaceutische of healthcare productieomgeving, met specifieke ervaring in kwalificatie van kleinschalige apparatuur en bijhorende software.
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Technische expertise in inspectieapparatuur en -technologieën (visuele inspectiemachines, leak testers, camera- en sensorsystemen, reject handling, automatisering).
Opstellen en documenteren van technische specificaties (EDS, P&ID’s, elektrische schema’s) en afstemmen met SME’s.
Werken volgens engineeringstandaarden en afstemmen met de Lead Engineer tijdens ontwerp, constructie en implementatie.
Opvolgen van constructie, installatie en inbedrijfstelling om te garanderen dat de installatie voldoet aan de specificaties.
Toepassen van projectmanagementtools (planning, budget, risico’s, rapportering, stakeholderbeheer).
Aansturen en opvolgen van contractors voor bouw, installatie en testen van de inspectieapparatuur.
Verantwoordelijk voor overdracht naar operations, inclusief volledige projectdocumentatie en projectafsluiting.
Opvolgen van opstartresultaten om te verzekeren dat de projectdoelstellingen behaald zijn.
Documenteren van constructie, verificatie en validatie in het engineering projectdossier.
Definiëren en uitvoeren van engineeringtesten, verificatie en validatie van inspectieapparatuur.
Opstellen van validatieaanpak, testprotocollen, verificatie- en validatiedocumenten.
Uitvoeren van testen en coördineren van goedkeuringen door SME’s en systeemverantwoordelijken.
Beheren en documenteren van afwijkingen en acties (CAPA’s, risicoanalyses, cGMP-review, document updates).
Profiel
Master/Bachelor in engineering of gelijkwaardig door ervaring.
Ervaring met inspectieapparatuur in farmaceutische productie is een pluspunt.
Kennis van testen, verificatie en validatie van systemen (ervaring in steriele omgeving is een plus).
Goede kennis van cGMP en compliancevereisten.
Communicatieve vaardigheden in Nederlands en Engels.
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
