QA Specialist

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

Our team is actively looking for a QA Specialist for a pharmaceutical laboratory in the canton of Neuchâtel.

Work Model: Hybrid (50% remote)

Eligibility: Valid Swiss work permit or Swiss/EU nationality required

Experience: 1 to 4 years in Quality Assurance within Pharmaceutical, Biotech, or Life Sciences industries

About the Opportunity

Our partner, an international pharmaceutical company based in Neuchâtel, is looking for a QA Specialist to join its Quality Assurance team.

This role focuses on QA Vendor Oversight, ensuring that products manufactured by external partners comply with GMP requirements and global quality standards. You will act as a key quality contact for contract manufacturers, supporting batch release activities, investigations, change controls, supplier quality management, and compliance initiatives.

Key Responsibilities

• 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.

Profile

• 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 a GMP-regulated pharmaceutical or biotechnology environment.
• Fluent German and English (written and spoken) is mandatory
• Good understanding of GMP, GDP, and pharmaceutical quality standards.