QA Raw Material, Compliance Specialist
We are currently seeking a QA Raw Material Compliance Specialist for an 8-month contract.
Responsibilities:
- Interact with internal/external stakeholders for material disposition and issue resolution.
- Serve as an SME in material receipt, testing, and disposition processes.
- Resolve complex issues, triage escalations, and train junior staff.
- Perform SAP transactions for material release and other Quality functions.
- Ensure compliance with GMP regulations for raw materials in commercial manufacturing.
- Act as the SME for technical transfers and collaborate with project teams.
- Update SOPs, stay current with industry compliance guidelines, and make informed testing decisions.
- Support the site as the final QA on change controls from MSAT, PW&L areas.
- Attend meetings, consult with quality management, and perform other assigned duties.
Qualifications:
- Education: Bsc/Msc in Science or Biotechnology.
- Experience: 5-10 years in Quality Assurance & GMP, with 5 years in a GMP environment.
- Skills: Strong knowledge of GMPs and regulations, experience with Trackwise, SAP, and Document Management systems.
- Attributes: Self-starter, excellent communicator, detail-oriented, effective team player.
- Language Skills: Proficient in German and English.
If you're a dynamic QA professional with a biotechnology background, ready to contribute to a global pharmaceutical company's success, apply now. Join us in shaping the future of pharmaceuticals!