Beschreibung
My client is actively looking for a Validation GMP / QA Specialist to join their Quality Assurance Team to oversee site operations to ensure GMP compliance is achieved and maintained by providing GMP advice and expertise for all Quality impacting related aspects.The ideal candidate will support the Validation Team with the verification process and the life-cycle of the production system (NOT with analytical validation).
The role involves (but is not limited to):
- Ensure the cleaning validation, hold-time validation, mixing validation, process validation and packaging validation are compliant to the regulations
- Develop, maintain and improve validation activities in order to meet current/future regulatory standards
- Managing documentation to ensure accuracy as per regulatory requirements
- Communication with other departments
- Responsibility to take necessary precautions in order to avoid danger of safety or health (use of apparatus/tools/machines/dangerous compounds/transportation as prescribed)
Requirements:
- + 3 years experience in QA (Pharmaceuticals/pharmacy, biotech or bio sciences)
- University degree related to the pharmaceutical area/chemistry
- English knowledge (fluent)
- Experience with FDA regulations is ideal
- Good experience with the Quality Systems during inspections
Project information:
- Start: November 2013/Asap
- Duration: at least 6 months, full-time
- Project area:Cantonof Schaffhausen
If this project sounds interesting for you, then please do not hesitate to contact me. Please send me your latest CV (word document), expected hourly rate and references.
I look forward to hearing from you.
To find out more about Real please visit www.realstaffing.com