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QA Specialist Batch record review / DSP (pharma, GMP)


New position for a QA Specialist DSP at a large pharmaceutical company in Leiden!

Job Description

For a pharmaceutical company in Leiden we are looking for Quality Assurance Specialist with knowledge of batch records, procedures and work instructions. This position is within the Down Stream Processing (DSP) department so experience with DSP and especially it's documentation side is very welcome. For example; AKTA, UFDF, POD or final fill experience within a GMP environment is a strong plus.


Responsibilities

  • Preparation and updating of Batch Records, Procedures and Work Instructions
  • Materials planning and ordering
  • Change control Assessor and perform implementation activities
  • Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
  • Readiness and release documentation
  • Release of clinical manufacturing batches
  • Represent Operations on cross functional project implementation teams
  • Monitoring and reporting of process performance using statistical process control
  • Troubleshooting
  • Investigating and resolving quality issues raised within the Manufacturing Department
  • Participate in/ Lead Cross Functional teams when required


Requirements

  • BSc, MSc or PDEng qualification in either Biochemistry, Pharmacy, Biotechnology, Science or Engineering, Bio-organic chemistry - with relevant QA experience.
  • Some form of DSP experience is a very strong plus (purification, AKTA, UFDF, POD, final fill)
  • Some form of process engineering is a very strong plus.
  • Valid Dutch work permit is a must, candidates not in possession of a work permit will not receive a response;


Benefits

  • Contract: 1 year via Oxford, realistic long- term perspective;
  • Salary: €3000 - €4500 gross monthly based on a full-time position;
  • Holidays: 25;
  • Working hours: full-time
  • Region: Leiden;
  • Vacancy number: 21752;