Beschreibung
QUALITY SPECIALIST IIIndustry: Pharmaceuticals
Location: Schaffhausen, Switzerland
Duration: 1 year (start within 1 month ideally)
Main tasks/secondary tasks/authority to issue instructions:
- Comply with the GMP, SHE and SOX requirements and guidelines associated with the respective function.
- Management and documentation of non-conformances
- Review & approval of Q-relevant master data, BOM, recipes, DMD/AGG codes, etc.
- Execution of batch splits and supervision of reworking including making the usage decisions for batches
- Key contact for production, logistics, regulatory affairs and external customers
- Review & Approval of product-specific SOPs, WIs, etc.
- Participation in regular staff meetings
- Membership in working and project groups as required and assigned
Functional objective and responsibilities
- Timely processing/closing of non-conformances (quality issues)
- Timely checking and final assessment of master data (parts lists, manufacturing instructions, Q-relevant material master data, DMD/AGG, etc.)
- Timely processing of batch splits and reworking including making the usage decisions for batches
- Review and approval of SOPs and operating instructions
- Assessor & Approver for CoCs
- Participation in projects
- QA-side support for other departments on GMP compliance issues
Qualifications & Experience
- A minimum of a Bachelor's Degree (MSc desired) in a scientific field
- 2-3 years of experience and already experience in the pharmaceutical sector (GxP)
- Ability to perform "hands on" troubleshooting and problem solving.
- Good technical understanding of manufacturing equipment and processes desired
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Business Fluent in German required
Keywords: Quality Specialist II, Switzerland, Schaffhausen, Pharmaceuticals, GMP, SHE, SOX, non-conformances, master data, batch, production, logistics, regulatory, affairs, SOPs, quality, manufacturing, CoCs, QA, pharmaceutical, GxP, ISO
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.