Expert Quality Control (m/w/d) (PR-34019219)

Ort: Frankfurt am Main, Hessen, Deutschland
Gehalt: Verhandelbar
Spezialisierungen: Life Sciences
Vertragsart: Freelance
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Expert Quality Control (m/w/d)

for:

  • Remediation implementation (documented)
  • Updated SOPs/work instructions/analytical documents (documented)

Activities

  • Apply the Data Integrity regulations as described in Eudralex vol 4., FDA 21 CFR part 11, WHO annex 5 as well as the company guidelines, SOPs, work instructions,
  • Document the activities and results as per Good Documentation Practices and compaby guidelines,
  • Contribute in equipment qualification (creating documents, performing PQ, ...)
  • Adapt and establish documentation with regard to the implementation of the data integrity requirement in instruction documents, manufacturing documents, as well as analytical documents, SOPs
  • Updates of excel sheets with regard to current data integrity requirements and defined remediations
  • Implement Remediation Activities in the context of company Data Integrity Implementation Program
  • Report to the project lead or deputy

Experience

  • Average of 2 to 5 years of hands-on GxP experience
  • Proven experience in quality control or quality assurance for quality control
  • Good Documentation Practice in Pharma and Biotech domains,
  • Solid experience with GxP regulations both FDA as well as EU
  • English spoken and written

Terms

  • Start: Februar 2023
  • Duration: till 31/12/2023
  • freelance contract, full-time

Jetzt bewerben