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 g LIMS.

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 g LIMS (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 g LIMS.
• 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 c GMP 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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