QA Specialist

QA-Specialist

The Role & What You Will Be Doing

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 escalate 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 escalate 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
• Supplier (CMO) oversight support
• 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