QA Specialist
Listed on 2026-09-01
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
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 OpportunityOur 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.
- 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.
- 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.
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