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PROJECT ENGINEER RMCS

Via Select HR

Staat 19 dagen op Jobat.be

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, The Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

For the chemical lab of one of our pharma clients in Puurs we are looking for a PROJECT ENGINEER RMCS (M/F).

 

PROJECT ENGINEER RMCS

Functieomschrijving

Our client is transferring  a vaccine DP production to Puurs. To release Drug Product material and to supply OMCL, QC testing requires  in house produced critical reagents (antibodies), internal control samples (DP), and Reference Standards (DP), together named RMCS (reference material and control standards. The client grange Castle will manufacture the critical reagents, and Puurs will characterize, qualify and bridge (equivalency testing) new lots of reagents.


As a PROJECT ENGINEER RMCS you will have the following responsibilities:

  • The project engineer is required to routinely manage RMCS materials
  • Qualify new  lots
  • File the qualification reports to the reg. Authorities
  • Requalify the current lots
  • Trending of control sample data
  • They will aid in the implementation of the required processes and procedures to allow standardized management of RMCS, qualification, and requalification, implementation, inventory and trending analysis  of control samples (data system, control charts, notifications and trending).
  • They will effectively bridge the first wave of in house manufactured lots of RMCS, thus allowing Puurs to switch from GSK to Puurs supply of reagents

Profiel

  • You have a University degree in a scientific discipline.
  • You have more than 1 year of experience in the pharmaceutical industry, more than 1 year of experience in GMP (validation/change control...) and more than 1 year of experience in Quality Control.
  • You have knowledge of:
    • qualification of critical reagents
    • reference standards
    • Quality control guidelines
    • control samples
    • chemical techniques: UPLC/HPLC, ICP-OES, AAS, Kjeldahl
    • biochemical techniques: ELISA
  • You are postive minded and you have a "can do" mentality.
  • You are communicative and you can work in a structured way.
  • You have good time management skills and you have an eye for quality.

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Mechelen - Lier

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Kenmerken

  • Functietype: Projectleider, technisch verantwoordelijke
  • Sector: Chemie en Pharmacie
  • Puurs (standplaats)
  • Meer over het bedrijf

Vereisten

  • Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type)

Aanbod

  • Onbepaalde duur
  • Zelfstandige
  • Voltijds

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