Type of employment
The QA Validation Specialist is responsible for ensuring the compliance of our three sites in Germany, including its state-of-the-art storage and environmental monitoring systems. He or she serves has frequent contact with our customers in client audits as well as internal stakeholders on site.
What will you do?
- Responsible of follow-up the inventory list of Equipment, Cold & Ambient Storage Rooms and ensure devices are maintained in a validated state.
- Review and approval of validation documents (URS/ DQ/ RA/ IQ/ OQ/ PQ and Summary Report)
- Review and approval of Re-Assessment/ Periodic Reviews (Equipment/ Cold & Ambient Storage Rooms)
- Support, Initial quality review and approver during investigation/deviation/ CAPA
- Gap analysis on current GMP requirements
- Perform Risk Analysis according to SOP/ internal Requirements
- Generation of re-qualification plans
- Generation of corresponding qualification / validation documents
- Creation, revision and updating of SOPs
- Participation in client and regulatory audits and inspections
- Good knowledge of Validation/ Qualification (EU GMP Annexes 11, 15, ISPE, Cycle V, URS/DQ/IQ/OQ/PQ)
- Education in Science or technical field (e.g. Bachelor or Master in Science or vocational training as laboratory technician, BTA, CTA, MTA, PTA or equivalent) is preferred
- Several years of related experience in a GMP environment
- High level of technical understanding in pharmaceutical or laboratory environment
- Document writing skills
- Good communication skills
- Automation/ computer software validation experience is preferred
- Business fluent in English.
- German language is preferred
- Ability to be a productive and supportive member of a project team, as well as working independently
- Employment within an innovative, growth-oriented organization.
- Outstanding career and development prospects.
- Company pension scheme and other fringe benefits.
- Exciting company culture, which stands for integrity, intensity, involvement and innovation