QA Specialist

Flexsis; Allschwil; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Flexsis is seeking a QA Specialist to provide operational QA support for IMPs, emphasizing documentation review, QA systems, and collaboration with CMOs to maintain inspection-ready QA operations.

The role requires a Life Sciences or related degree and 1–3 years in QA/QC or pharma manufacturing, with strong GMP knowledge and attention to detail. English is essential, German/French a plus, and eDMS/SAP experience is preferred.

Qualifikationen

• Bachelor’s degree in Life Sciences, Pharmacy or related discipline.
• 1–3 years of QA, QC, or pharmaceutical manufacturing experience.
• Practical knowledge of (c)GMP/GDP principles.
• Hands-on GMP documentation review (batch records, deviations, change controls).
• Strong organizational skills and ability to manage multiple priorities.
• High attention to detail and a structured, process-driven mindset.
• English proficiency; German or French a plus.

Aufgaben

• Batch documentation & release support.
• Perform completeness checks of batch documentation for IMPs.
• Review executed batch records from CMOs for GMP compliance.
• Identify, document, and elevate discrepancies and support their resolution.
• Prepare and compile batch documentation packages to support QA release.
• eDMS and ERP support; ensure accuracy of QA records in ERP.
• Maintain trackers for batch documentation and quality events; ensure transparency.
• Ensure documentation/records are inspection-ready at all times.
• Support intake, logging, and tracking of quality events and change controls.
• Coordinate with internal stakeholders and CMOs to ensure timely progression and closure.

Kenntnisse

QA

GMP/GDP knowledge

Documentation review

Batch records review

Change controls

Quality systems

Attention to detail

Ausbildung

Bachelor’s degree in Life Sciences/Pharmacy or related discipline

Tools

Veeva Vault (eDMS)

SAP ERP

Jobbeschreibung

Provide operational QA support for investigational medicinal products (IMPs), focusing on documentation review, quality system execution, and coordination with CMOs, ensuring timely, compliant, and inspection-ready QA operations.

Every day, we rise to the challenge to make a difference and here’s how the QA Specialist role will make an impact:

• Bachelor’s degree in Life Sciences, Pharmacy or related discipline
• 1-3 years of experience in QA, QC, or pharmaceutical manufacturing environment
• Practical knowledge of (c)GMP/GDP principles
• Hands-on experience reviewing GMP documentation (e.g., batch records, deviations, change controls)
• Strong organizational skills and ability to manage multiple priorities
• High attention to detail and a structured, process-driven mindset
• Ability to identify issues, propose solutions, and elevate appropriately
• Strong written and verbal communication skills in English (German and/or French are a plus)
• Preferred:
• Experience with electronic quality systems (eDMS such as Veeva Vault)
• Experience with ERP systems (e.g., SAP)
• Experience working with CMOs or external partners
• Experience in clinical supply or IMP handling

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Batch documentation & release support
• Perform completeness checks of batch documentation for investigational medicinal products (IMPs)
• Conduct first-pass review of executed batch records from CMOs for GMP compliance
• Identify, document, and elevate discrepancies and support their resolution
• Prepare and compile batch documentation packages to support QA release
• eDMS and ERP support
• Support document management activities in eDMS (e.g., upload, routing, version control)
• Ensure accuracy and completeness of QA-relevant records in ERP systems (e.g., batch status, material and batch data)
• Maintain trackers for batch documentation, quality events, and actions, ensuring transparency on status and timelines
• Ensure documentation and records are always maintained in an inspection-ready state
• Quality events support
• Support intake, logging, and tracking of quality events (e.g., temperature excursions, deviations, complaints) and change controls
• Perform initial completeness and consistency checks of investigations from CMOs
• Proactively follow up with internal stakeholders and support coordination of requests to CMOs via established communication channels to ensure timely progression and closure
• Escalate delays, quality concerns, or risks to senior QA
• Support maintenance and periodic review of Quality Agreements with CMOs
• Collect and consolidate CMO quality metrics (e.g., deviations, complaints, on-time performance)
• Support preparation of quality KPI reports and trend overviews