Expert Vendor Qualification (7087)

CTC Resourcing Solutions; Bern; Vor Ort; CHF 166.000 - 240.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is partnering with a specialist biotherapeutics manufacturer in Bern, Switzerland to recruit an Expert Vendor Qualification on a 6-month contract with extension possibilities.

The role leads GxP supplier qualification activities and audits to ensure GMP-compliant vendors and corresponding documentation. Candidates should have a life sciences or engineering degree, 5+ years in pharma, and fluency in English.

Qualifikationen

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• A Degree in life sciences and/or engineering.
• At least 5 years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience.
• Demonstrated experience in quality assurance and regulatory compliance with GxP, Swissmedic, US FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics.
• Direct experience in quality oversight of GxP-compliant vendor qualification processes, including planning, documentation review, and audit execution.
• Deep knowledge of GMP and global regulatory requirements, e.g. GMP, FDA, EU and other relevant GxP regulations.
• Effective collaboration with internal and external stakeholders.
• Fluent in English (spoken and written).

Aufgaben

• Execute GxP supplier qualification activities.
• Lead vendor qualification including document review and audit execution.
• Ensure qualification of vendors providing GxP-relevant equipment and services.
• Act as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls.
• Establish and Maintain Overview of already Qualified and to be Qualified Vendors.

Kenntnisse

Quality assurance

Regulatory compliance

Vendor qualification

GxP documentation

Audit execution

Ausbildung

Life sciences degree

Engineering degree

Jobbeschreibung

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

For their site in Bern, Switzerland, our client is current looking for a:

Expert Vendor Qualification

on a 6-month contract, with possibilities of extension.

Main responsibilities:

• Execute GxP supplier qualification activities.
• Lead vendor qualification including document review and audit execution.
• Ensure qualification of vendors providing GxP-relevant equipment and services.
• Act as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls.
• Establish and Maintain Overview of already Qualified and to be Qualified Vendors.

Qualifications and experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• A Degree in life sciences and/or engineering.
• At least 5 years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience.
• Demonstrated experience in quality assurance and regulatory compliance with GxP, Swissmedic, US FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics.
• Direct experience in quality oversight of GxP-compliant vendor qualification processes, including planning, documentation review, and audit execution.
• Deep knowledge of GMP and global regulatory requirements, e.g. GMP, FDA, EU and other relevant GxP regulations.
• Effective collaboration with internal and external stakeholders.
• Fluent in English (spoken and written).