QA Specialist – GMP/IMPs, Documentation & Compliance

CTC Resourcing Solutions; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a QA Specialist to support GMP documentation review, QA activities for IMPs, and coordination with CMOs. The role focuses on ensuring documentation completeness, inspection readiness, and timely QA operations.

The ideal candidate will have a Life Sciences/Pharmacy degree and 1–3 years of GMP experience, with strong attention to detail and English communication skills; German or French would be an advantage.

Qualifikationen

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• 1–3 years of experience in QA, QC, pharmaceutical manufacturing, or a GMP environment.
• Knowledge of GMP/GDP principles.
• Experience reviewing GMP documentation (batch records, deviations, change controls).
• Strong organizational and time-management skills.

Aufgaben

• Review GMP documentation and executed batch records for completeness and compliance.
• Support QA release activities for Investigational Medicinal Products (IMPs).
• Prepare and maintain batch documentation packages.
• Manage QA documentation within eDMS, including Veeva Vault.
• Maintain QA-related records and batch info in SAP.
• Track deviations, change controls, complaints, and temperature excursions.
• Perform initial reviews of investigations from CMOs.
• Coordinate with internal and external partners to resolve quality topics.
• Support maintenance and review of Quality Agreements with CMOs.
• Consolidate CMO quality metrics and contribute to KPI reporting.
• Ensure QA documentation remains accurate and inspection-ready.

Kenntnisse

GMP/GDP principles

English communication

Quality documentation review

Time management

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences/Pharmacy or related

Tools

Veeva Vault

SAP

Jobbeschreibung

CTC Resourcing Solutions is seeking a QA Specialist to support GMP documentation review, QA activities for IMPs, and coordination with CMOs. The role focuses on ensuring documentation completeness, inspection readiness, and timely QA operations.

The ideal candidate will have a Life Sciences/Pharmacy degree and 1–3 years of GMP experience, with strong attention to detail and English communication skills; German or French would be an advantage.