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We are working with a leading pharmaceutical organization that partners with global pharma and biotech companies to develop and manufacture pharmaceutical products. They are expanding their team and looking for a Quality Assurance Specialist to support the product lifecycle at their site in Switzerland.
The Role
As a Quality Specialist, you'll play a key role in ensuring product quality and compliance throughout the full project lifecycle. This is an opportunity to work on innovative medicines in a highly regulated environment, supporting projects from development through to commercial release.
Key Responsibilities
- Act as the technical QA representative for client projects, providing expert input on quality-related matters.
- Deliver QA oversight across all phases of projects, ensuring compliance with GMP and regulatory standards.
- Review and assess product-related quality records for accuracy and completeness.
- Support method transfer, qualification, and validation activities in collaboration with QA teams.
- Issue batch records and provide technical support for batch documentation review.
- Act as a subject matter expert during audits and inspections.
- Provide input for regulatory submissions and coordinate timely batch manufacturing and QC release.
- Prepare and approve technical documentation such as SOPs, Master Batch Records, specifications, and sampling plans.
What We're Looking For
- Relevant degree such as a Science or Manufacturing
- Minimum 3 years' experience in a technical QA role within a GMP environment; sterile manufacturing experience is a bonus.
- Strong understanding of GMP principles and regulatory compliance.
- Excellent communication and teamwork skills, with fluency in English. German is a bonus
- Experience in microbiology or QC is advantageous.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.
