QA Validation Specialist PQR
Swisslinx
Auf einen Blick
- Veröffentlicht:21 Dezember 2024
- Pensum:100%
- Vertragsart:Festanstellung
- Arbeitsort:Upper Valais
On behalf of our client, a leading international biotechnology company based in Visp, Swisslinx is looking for a QA Validation Specialist PQR. In this role, you will lead quality assurance efforts by driving process validation excellence, managing Product Quality Reviews (PQRs), ensuring compliance with GMP standards, and acting as a key liaison during customer audits.
Contract type - Contract
Start Date - January
Location - Visp
Workload - 100%
Duration - 12 months
Your Mission
* Ensure the trainings required to the Process Validation Specialist with focus on Product Quality Review are completed.
* Active participation and contribution to the validation team to ensure the experience is shared and the practices are further developed
* Support the project teams to ensure compliance with company SOPs and related documents.
* Preparation and approval of the monthly PQR Newsletter.
* Maintenance of the PQR status overview list CHVI-204288.
* Participation in the preparation of process specific PQRs review and approval of PQRs.
* Evaluation and approval of change requests, deviation and SOPs concerning PQRs.
* Contact person for PQR/CPV during customer audits.
Your Background
* Degree in the Life Sciences, Pharmacy, Engineering, or a related field.
* 5+ years experience in a similar role.
* Proven experience in process validation, Product Quality Reviews (PQRs), and working within GMP-regulated environments in the pharmaceutical or biopharmaceutical industry.
* Familiarity with quality systems, including change control, deviation management, and SOP development, as well as experience with customer audits and compliance evaluations.
* Ability to contribute actively to cross-functional teams, ensuring training, knowledge-sharing, and alignment with organizational best practices.
* Strong organizational skills to maintain PQR status overviews, prepare newsletters, and handle complex documentation and reporting tasks efficiently.
* Confidence in liaising with internal teams and external customers during audits, ensuring clear and effective representation of quality processes.
What's on offer
* A 12 month contract.
* A great opportunity to develop your career at a leading international biotechnology company.
* A competitive salary.
If this sounds like the right fit for you, don't hesitate to apply! For more information, please reach out directly to Veronika von Mentzer, Recruiter: Write an email.
Contract type - Contract
Start Date - January
Location - Visp
Workload - 100%
Duration - 12 months
Your Mission
* Ensure the trainings required to the Process Validation Specialist with focus on Product Quality Review are completed.
* Active participation and contribution to the validation team to ensure the experience is shared and the practices are further developed
* Support the project teams to ensure compliance with company SOPs and related documents.
* Preparation and approval of the monthly PQR Newsletter.
* Maintenance of the PQR status overview list CHVI-204288.
* Participation in the preparation of process specific PQRs review and approval of PQRs.
* Evaluation and approval of change requests, deviation and SOPs concerning PQRs.
* Contact person for PQR/CPV during customer audits.
Your Background
* Degree in the Life Sciences, Pharmacy, Engineering, or a related field.
* 5+ years experience in a similar role.
* Proven experience in process validation, Product Quality Reviews (PQRs), and working within GMP-regulated environments in the pharmaceutical or biopharmaceutical industry.
* Familiarity with quality systems, including change control, deviation management, and SOP development, as well as experience with customer audits and compliance evaluations.
* Ability to contribute actively to cross-functional teams, ensuring training, knowledge-sharing, and alignment with organizational best practices.
* Strong organizational skills to maintain PQR status overviews, prepare newsletters, and handle complex documentation and reporting tasks efficiently.
* Confidence in liaising with internal teams and external customers during audits, ensuring clear and effective representation of quality processes.
What's on offer
* A 12 month contract.
* A great opportunity to develop your career at a leading international biotechnology company.
* A competitive salary.
If this sounds like the right fit for you, don't hesitate to apply! For more information, please reach out directly to Veronika von Mentzer, Recruiter: Write an email.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
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- transferring where applicable my personal information to a country outside the EEA/EFTA
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Kontakt
Swisslinx