Main Responsibilities:
- Collaborate closely with cross-functional teams to work on growth projects as per site quality objectives and strategic goals. Ensure that project timelines and deliverables under the responsibility of QA/QC are fulfilled.
- Provides guidance and quality oversight for QC
- Support growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system)
- Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed.
- Review and Approval of GMP relevant documents from quality control, including SOPs with focus on implementation of gLIMS.
- Supervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs)
- Write or revise SOPs in the area of expertise and be the owner of these documents.
- Support QA for QC raw data review, as deemed required
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)
- Management and reporting of KPIs
- Perform/support inspections and audits as required.
- Performs other duties as assigned
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- 8 years + experience in projects in implementation of laboratory execution systems, within a quality-focused environment.
- Strong background in cGMP regulations, including US, European and Japanese Pharmacopoeia.
- Very good knowledge in laboratories/laboratory equipment/software qualification/validation.
- Experience in interaction with health authorities (FDA, Swissmedic, etc.).
- Structured, focused and well-organized working attitude.
- Open-minded for new ideas and suggestions, agile, highly motivated and dynamic drive.
- Pragmatic and solution-orientated mindset.
- Fluent in English, German language is nice to have
- Project management certification would be considered as advantage (Green/Black Belt etc)
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