Providing Flexible Resourcing Solutions
Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.
An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.
QA Validation Specialist PQR– 6262
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Validation Specialist PQR for a contract role of 12 months to be based in the Valais area, Switzerland.
Main Responsibilities:
1. Ensure the trainings required to the Process Validation Specialist with focus on Product Quality Review are completed.
2. Active participation and contribution to the validation team to ensure the experience is shared and the practices are further developed.
3. Support the project teams to ensure compliance with company SOP CHVI-348, CHVI-301000 and related documents.
4. Preparation and approval of the monthly PQR Newsletter.
5. Maintenance of the PQR status overview list CHVI-204288.
6. Participation in the preparation of process specific PQRs review and approval of PQRs.
7. Evaluation and approval of change requests, deviation and SOPs concerning PQRs.
8. Contact person for PQR/CPV during customer audits.
Qualifications and Experience:
1. Relevant working/residency permit or Swiss/EU-Citizenship required.
2. BS Degree or equivalent in Engineering, Chemistry, Life Science.
3. Relevant years of experience in Process Validation with focus on Product Quality Review.
4. Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
5. Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
6. Ability to interface and communicate directly with clients is required.
7. Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
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