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

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