Senior QA Expert / Senior QA Expertess

Senior QA Expert for QC – 7084 URA

Our client, a global market leader in the production and process support of active pharmaceutical ingredients across both the chemical and biotechnology sectors, is seeking a Senior QA Expert for QC. This position is a 6-month contract with a 60% workload. The Senior QA Expert will be responsible for overseeing QC to support departmental projects and objectives in accordance with established timelines. Maintaining adherence to standards and compliance with GMP regulations within their manufacturing unit in Stein is essential. This role will require 100% onsite presence.

This project involves the implementation of a laboratory management system, gLIMS. The ideal candidate will have over 2 years of experience with LIMS, along with at least 7 years of Quality Assurance experience (a mix of QA and QC experience is acceptable).

Main Responsibilities:

• Collaborate closely with cross-functional teams to advance growth projects in alignment with site quality objectives and strategic goals, ensuring project timelines and deliverables are met.
• Provide guidance and quality oversight for QC.
• Act as the primary point of contact in QA for the implementation of gLIMS (laboratory execution system).
• Offer QA support and guidance to the Quality Control (QC) department, ensuring compliance with GMP requirements and adherence to SOPs.
• Review and approve GMP-relevant documents from quality control, including SOPs, with a focus on the implementation of gLIMS.
• Supervise and conduct GMP compliance activities such as change requests (CRs), document management, and non-conformities (DRs).
• Write or revise SOPs in the area of expertise, taking ownership of these documents.
• Support QA for QC raw data review, as required.
• Ensure compliance with internal and external quality and safety guidelines, including quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.
• Management and reporting of KPIs.
• Perform and/or support inspections and audits as necessary.
• Perform other duties as assigned.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU citizenship required.
• More than 8 years of experience in projects involving the implementation of laboratory execution systems within a quality-focused environment.
• Strong background in cGMP regulations, including US, European, and Japanese Pharmacopoeia.
• Extensive knowledge of laboratories, including laboratory equipment and software qualification/validation.
• Experience interacting with health authorities (e.g., FDA, Swissmedic).
• Structured, focused, and well-organized working style.
• Open-mindedness to new ideas and suggestions, combined with agility, high motivation, and a dynamic approach.
• A pragmatic and solution-oriented mindset.
• Fluency in English; proficiency in German is a plus.
• Project management certification is an advantage (e.g., Green/Black Belt).

Apply online using the form below. Please note that only applications matching the job profile will be considered.