Quality Operations Specialist
Jocelyn Blackham is recruiting for a Quality Operations Specialist to join a top global pharmaceutical company at their site based in Lucerne on a contract basis for 2 years.
The successful candidate will have accountability for Good ManufacturingPractice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, SOP management, and site procedures.
Quality Operations Specialist Role:
- Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards
- Ensure deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions
Key duties will include:
- Performing SOP review and approval within Quality and for functional area procedures
- Participating in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues
- Applying critical decision making, project management skills
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Experience in pharmaceutical, biotech or other regulated industry
- Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols
- Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES
- cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment is preferred
- A Master’s Degree in Engineering, Sciences or related field is advantageous
- Fluent in English and German This is an excellent opportunity to join a company certified as one of the ‘best employers in Switzerland’.
Benefits include competitive pay and great working environment and supportive team.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote reference 53757 in all correspondence.