Master Data Quality Specialist

  • Location: Hulshout
  • Type: Contracting
  • Job #20009

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 Quality Specialist

Onze klant is op zoek naar iemand voor het beheer van specificities, documenten en Master Data Quality. In deze rol sta je in contact met een grote verscheidenheid aan interne en externe teams en stakeholders
Locatie: Hulshout

Belangrijkste taken in jouw rol zijn:

  • Beheer van specificaties in IPI en QualityDocs
  • Opmaak, aanpassen, goedkeuren en archiveren van
  • Goods Receipt Slips
  • Supplier Material Specifications, inclusief het opladen ervan in de databank
  • Compliance met farmacopees: zelfstandig beslissen, opvolgen en coördineren van implementatie van updates
  • Initiëren, nakijken, impact assessment en goedkeuren van GCM’s; tijdig uitvoeren van change tasks
  • Beheer van statements: TSE/BSE, residuele solventen, allergenen, …
  • Opmaken van statements voor GRA, Global CMC, registratiedoeleinden
  • Opmaken van certificaten voor herwerkingen, registratiedoeleinden
  • Nakijken en goedkeuren van
  • Lab Data Sheets (LDS) en Approved Supply Chains in het Document Management Systeem
  • LIMS-configuratie via e-requests
  • SAP-configuratie
  • Global Concurrence Requests (GCR’s) van andere sites
  • Compliance met wat geregistreerd is
  • behandelen van notificaties
  • up to date houden van specs en testmethodes, actives en gewijzigde processen
  • opvragen van registratie-info en registratie-status
  • Beheer en wijzigingen aan Quality master data in SAP, bij code-creaties en -extensies, inclusief review van MMR’s en het initiëren van GCR’s en Appians voor
  • Shelf life, Expiry Date Format, rounding rules
  • bewaarcondities in de Label Data
  • Registered Country Table (RCT)
  • Source of Supply Table

• Andere QM-gerelateerde velden

  • Aanmaken en wijzigen van QIR’s (Quality Info Records) in SAP
  • Aanmaken, wijzigen, goedkeuren en archiveren van Coding Notices voor finished producten en bulken op basis van code-creaties en -extensies, GCM, …
  • Opzetten van RCT op basis van destination control forms en van TOI (Testing on importation)
  • Beheer van PCR Trace Tables in SAP
  • Beheer van de Positieve lijsten van elke IPT
  • Beheer van SOPs voor de afdeling
  • Deelname aan of leiding van specifieke projecten
  • Bestaande concepten in vraag stellen en voorstellen doen tot optimalisatie
  • Vertegenwoordigen van het team intern & extern

Your Profile:

Must

  • Diploma: Universitair of gelijkwaardig ((industrie-)apotheker, bio-ingenieur, ingenieur in de (bio-)chemie, licenciaat/ master (bio) chemie, biomedische wetenschappen…)
  • MS Office
  • Analytische geest
  • Organisatievermogen
  • Sterke administratieve vaardigheden
  • Vlot in zowel gesproken als geschreven Nederlands en Engels
  • Leiderschapskwaliteiten

Nice to have

  • Ervaring met farmacopees
  • Ervaring met het beheer van lifecycle-documenten
  • Ervaring met projectmatig werken

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 Validation and Qualification

  • Location: Hulshout
  • Type: Contracting
  • Job #19991

Support in Validation and Qualification

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!

Job Description

As part of a site wide modernization program, the resource will report and provide support to the local program lead. He/She will be responsible for the validation & qualification activities of shopfloor systems including data integrity. The scope includes automation systems, computer systems and equipment’s linked to pharmaceutical manufacturing. All of this in accordance with our company standard processes and compliance rules.

Areas of responsibilities are:

·       Qualification & Validation

o   Creation of validation lifecycle documents (Requirements, Design specs, FAT/SAT, IQ/OQ/PQ) according to the MSD standards

o   Testing of shopfloor systems

o   Execution of validation protocols

o   Creation of Standard Operating Procedures

·       Operations/Production Support

o    Support operations/production at startup of project

Profile:
– You have knowledge of GAMP5
– You have knowledge of System Validation Lifecycle
– You have knowledge of Pharmaceutical Industry and Standards (GDP, GxP)
– You have a good knowledge of Dutch and English (written/spoken)
– You have a minimal experience and knowledge of GMP, GDP and qualification in a pharmaceutical engineering environment
 

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 Project Engineer Filling- and Packaging Equipment

  • Location: hulshout
  • Type: Contracting
  • Job #19990

Support Project Engineer Filling- and Packaging Equipment

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!

Job Description

You will be responsible for the execution of projects (filling- and packaging equipment, clean room):
• Filling- and packaging equipment scope (New equipment and modification of existing equipment)
• Clean room scope (modification of existing room)

Areas of responsibilities are:

·       Project execution

·       Project management

·       Assistance during commissioning of the new/modified equipment

·       Assistance during FAT and SAT of the new/modified equipment

·       Assistance during relocation of packaging line

·       Assistance in set-up changes in existing clean rooms

·       Equipment Qualification

·       Protocols generation (all documents linked with the qualification)

·       Protocol execution

·       Qualification reports

·       Room Qualification

·       Protocols generation

·       Protocol execution

·       Qualification reports

·       Technical review of as-build files after execution.

·       Operations/Production Support
o Communication with production to discuss planning/organization
o Communication with suppliers to discuss planning/organization

Profile:

·       You have experience in filling- and packaging equipment for the pharmaceutical industry

·       You have experience in clean room

·       You have a good knowledge of Dutch/English (Verbal/Written)

·       You can write documents in English

Specific requirements (skills) or experience for the assignment:

·       You have Ownership

·       You can Work independently

·       You are Open, honest and curious

·       You can have open communication with customer and supplier

·       You are Flexible and creative person with strong analytical skills

·       You need for hands-on mentality

·       You have Minimum Bachelor level
 

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!