Expert Quality Control (m/w/d)

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