Anna Hrehlevych
Consultant
QA Validation Specialist (Fixed-Term Contract)
Valais, Switzerland
Apply by 23 Sept 2026
Competitive
Job Ref.: BH-57858-2
Job Description
We are seeking an experienced QA Validation Specialist to support a major biologics manufacturing expansion project in canton Valais. You will play a key role in ensuring GMP equipment, facilities, and systems remain qualified, validated, and inspection-ready throughout the project lifecycle.
This is a hands-on role requiring strong expertise in validation, qualification, change control, and GMP documentation review. The successful candidate will be able to quickly integrate into a fast-paced project environment and provide immediate value.
Key Responsibilities
- Review and approve validation protocols, reports, SOPs, deviations, CAPAs, and change controls.
- Provide QA oversight of equipment, facility, and utility qualification and validation activities.
- Assess the impact of changes to GMP systems and ensure appropriate validation activities are completed.
- Ensure systems remain in a validated state and comply with EU GMP and FDA requirements.
- Support qualification activities including:
- IQ, OQ, and PQ
- Autoclaves
- Clean Utilities
- Shipping Validation
- Temperature Mapping
- Develop validation protocols from approved validation plans when required.
- Use and maintain quality systems including TrackWise, Kneat, DMS, and LIMS.
- Support internal audits, regulatory inspections, and continuous improvement initiatives.
- German is mandatory
- 15 - 20 overall years of experience in GMP-regulated pharmaceutical and biopharmaceutical manufacturing sites.
- Strong knowledge of IQ, OQ, PQ, validation lifecycle management, and maintaining a validated state.
- Experience reviewing and approving GMP documentation, including:
- SOPs
- Validation protocols and reports
- Deviations
- CAPAs
- Change Controls
- Working knowledge of EU GMP and FDA regulations.
- Fluent English; German is an advantage.
- Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or related discipline preferred, though equivalent industry experience will also be considered.
- Able to hit the ground running in a critical project phase.
- Comfortable working independently and managing priorities.
- Strong attentiuality on to detail and qmindset.
- Effective communicator with the ability to work across Engineering, Operations, Quality, and external stakeholders.
- Thrives in a collaborative and multicultural environment.
By applying for this role, you consent to SGI contacting you by telephone regarding recruitment services, market updates, and relevant business opportunities
We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.
Source Group International Ltd is acting as an Employment Business in relation to this vacancy