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Senior QC Specialist (Freelance)

  • Job type: Contract
  • Location: Hannover (30165), Niedersachsen
  • Salary: Competitive
  • Job reference: 337023/001_1537800275
  • Sector: Quality Control, EPM Scientific
  • Date posted: 24/09/2018

The Role:

A Global health care leader (providing innovative medicines, vaccines, therapies) is seeking QC specialists to support one of their Biotech manufacturing sites in Germany.

This is an opportunity to work with a market leader in drug development, working with the site to transition to commercial manufacture.

  • Coordinate testing of produced medicine batches for commercial use, working with the QC department colleagues to guarantee timely release.

  • Ensure regulatory compliance with FDA and EMA.

  • Preparation of specifications, SOPs, sampling, testing and documentation of all incoming starting materials, drug products.

  • Implementation, qualification/validation of analytic methods (ICH) used for characterisation and control of cell banks, raw materials, drug products.

  • Performance of quality control testing of cell banks, raw materials and drug products (DP).

  • Management of reference standards, retention samples, analytic (assay) cell banks used for drug substance and drug product analysis

  • Management of stability programs (real-time, stressed, accelerated).

  • Performance of process validation support testing

  • Ensuring the high technical and scientific standard of the analytic equipment used and the analytic methods.

    • Collaborate with QA to investigate product defects

    • Assist the team in managing deviations.

  • Ensure all laboratory work complies with the associated GMP, safety and environmental guidelines

12 month contract

Skills and Experience Required

Education:

University / Fachhochschulausbildung in the field of analytic chemistry (or a similar education)

Languages:

  • English spoken and written

  • German desired, but not mandatory

Experience:

  • 7+ years of experience in pharmaceutical analysis

  • Fully conversant in cGMP

  • Experience working with Vaccine production

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