QA Specialist – Vendor Oversight (Pharma, Hybrid)

Gi Life Sciences; Neuenburg; Hybrid; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Gi Life Sciences in Neuchâtel is seeking a QA Specialist to join its Quality Assurance team. You will focus on QA Vendor Oversight, ensuring external manufacturing partners comply with GMP and global quality standards, and support batch release activities.

The role involves investigations, change controls, supplier quality management, CAPAs, and regulatory initiatives within a GMP-regulated environment. Fluency in German and English is mandatory.

Qualifikationen

• Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field.
• 1 to 4 years of experience in Quality Assurance within GMP-regulated pharmaceutical or biotechnology environment.
• Fluent German and English (written and spoken).
• Good understanding of GMP, GDP, and pharmaceutical quality standards.

Aufgaben

• Manage Quality Assurance activities related to external manufacturing partners and CMOs.
• Maintain strong working relationships with contractors and quality representatives.
• Lead discussions on quality topics including deviations, change controls, complaints, OOS investigations, and CAPAs.
• Review and approve quality documentation, validation protocols, validation reports, investigations, and change controls.
• Prepare and review Batch Release Packages to support final product disposition.
• Support product release activities while ensuring GMP and regulatory compliance.
• Manage and assess change controls, including QA approval and impact evaluation.
• Support complaint investigations and vendor-related quality issues.
• Review Process Validation and Technology Transfer documentation.
• Participate in Annual Product Quality Reviews (APQR/PQR).
• Draft, review, and manage Quality Agreements with external partners.
• Participate in supplier audits, self-inspections, and regulatory inspections.
• Maintain quality metrics, trend analyses, and quality databases.
• Contribute to the continuous improvement of Quality Systems.
• Author and review SOPs, work instructions, and quality procedures.
• Support GMP and GDP compliance activities across the organization.

Kenntnisse

German

English

Ausbildung

Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field

Jobbeschreibung

Gi Life Sciences in Neuchâtel is seeking a QA Specialist to join its Quality Assurance team. You will focus on QA Vendor Oversight, ensuring external manufacturing partners comply with GMP and global quality standards, and support batch release activities.

The role involves investigations, change controls, supplier quality management, CAPAs, and regulatory initiatives within a GMP-regulated environment. Fluency in German and English is mandatory.