QA Specialist in Basel

Overview

In this role you ensure GMP-compliant QA operations for Investigational Medicinal Products, focusing on documentation and quality systems. You will work with CMOs and internal stakeholders to keep batch documentation accurate, inspection-ready, and timely. You shape quality by reviewing GMP records, handling deviations, and supporting QA release activities, contributing to robust oversight of IMP quality. This position offers impact through cross-functional collaboration to sustain compliant manufacturing and continuous improvement. You will operate in a process-driven, quality-focused environment that values precise documentation and timely issue resolution.

Verantwortungsbereiche

• Review GMP documentation and executed batch records for completeness and compliance
• Support QA release activities for Investigational Medicinal Products (IMPs)
• Identify, document, and escalate discrepancies and quality issues
• Prepare and maintain batch documentation packages
• Manage QA documentation within electronic document management systems (eDMS), including Veeva Vault
• Maintain accurate QA-related records and batch information in ERP systems such as SAP
• Track deviations, change controls, complaints, temperature excursions, and other quality events
• Perform initial reviews of investigations received from CMOs
• Coordinate with internal stakeholders and external manufacturing partners to ensure timely resolution of quality topics
• Support the maintenance and review of Quality Agreements with CMOs
• Collect and consolidate CMO quality metrics and contribute to KPI and trend reporting
• Ensure QA documentation remains accurate, complete, and inspection-ready

Zentrale Anforderungen

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field
• 1–3 years of experience in QA, QC, pharmaceutical manufacturing, or a similar GMP environment
• Good practical knowledge of GMP/GDP principles
• Experience reviewing GMP documentation such as batch records, deviations, and change controls
• Strong organizational and time-management skills, with the ability to manage multiple priorities
• High attention to detail and a structured, process-oriented approach
• Ability to identify quality issues, propose solutions, and escalate appropriately
• Strong written and verbal English communication skills
• German and/or French would be an advantage

• Strong organizational and time-management skills
• Attention to detail
• Effective written and verbal communication
• GMP/GDP principles
• eDMS (including Veeva Vault)
• SAP