Senior QA Expert for QC Specialist (7084)

Senior QA Expert for QC – 7084 URA

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Senior QA Expert for QC The Sr. QA Expert for QC role is a 6M contract with 60% workload . QA responsible for QC oversight to support departmental projects and objectives according to agreed timelines. Ensures adherence to standards and compliance with GMP regulation in their manufacturing unit in Stein . Review, approve and release of all batch-related microbiology documents. 100% onsite presence will be required.

The Project is related to implementation of a laboratory management system gLIMS. The candidate must have 2+ years of experience with LIMS. The candidate must have 7+ years of Quality Assurance experience (a mix of QA and QC is acceptable).

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, includingSOPs 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.
• Experiencein 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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