Senior QA Expert for QC Specialist (7084)

CTC Resourcing Solutions; Basel; Vor Ort; CHF 90.000 - 130.000; Teilzeit

Zusammenfassung

Senior QA Expert for QC role on a 6M contract (60% workload) onsite in Stein, Basel region. You will oversee QC activities, ensure GMP compliance, support gLIMS implementation, and manage QA/QC documentation and KPIs. 8+ years in QA/QC, experience with LIMS, and interaction with health authorities preferred.

Fluent English; German a plus. Residency in Switzerland/EU required. Collaboration with cross-functional teams to meet project timelines and quality objectives.

Qualifikationen

• 8+ years in QA/QC in pharma or related field.
• Strong background in cGMP regulations (US/EU/Japanese Pharmacopoeia).
• Experience with laboratory execution systems and LIMS implementations.

Aufgaben

• Provide QC oversight to support projects and meet timelines.
• Guide QC activities and ensure GMP compliance and SOP adherence.
• Lead QA for gLIMS implementation and related documentation.
• Review GMP documents and manage changes, deviations, and CAPAs.
• Prepare and revise SOPs within area of expertise.

Kenntnisse

QA oversight

GMP compliance

QC collaboration

LIMS implementation

KPIs management

Tools

gLIMS

Jobbeschreibung

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