Vendor Qualification Associate for CSL Behring in Bern

We make it GmbH; Lavamünd; Vor Ort; EUR 95.000 - 127.000; Vollzeit

Zusammenfassung

CSL Behring AG in Bern seeks a Vendor Qualification Associate to lead GxP supplier qualification activities and audit execution. The role supports qualification of vendors for GxP-relevant equipment and services at the site level.

The position requires a life sciences or engineering degree (advanced degree preferred), 5+ years in pharma, and strong knowledge of GMP and regulatory guidance including US FDA and EU. English fluency is essential.

Qualifikationen

• Degree in life sciences or engineering; advanced degree preferred.
• 5+ years in pharmaceutical industry or equivalent.
• Experience in quality assurance and regulatory compliance with GxP, Swissmedic, FDA, TGA, EU.
• Direct experience in quality oversight of GxP vendor qualification processes.
• Strong communication and cross-functional collaboration skills.
• 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 for Site BRN.

Kenntnisse

GxP compliance

Vendor qualification

Audits

Regulatory knowledge

Quality assurance

Ausbildung

Life sciences degree

Engineering degree

MSc preferred

Tools

GxP documentation systems

Audit tools

Jobbeschreibung

We make it GmbH is a company operating nationally in Switzerland. Thanks to many years of successful experience, it has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our customer, the company CSL Behring, we are searching for:

Vendor Qualification Associate

Description

CSL Behring AG in Bern specializes in the manufacture of drugs for the treatment of immune deficiencies and immune dysfunction, as well as drugs for rhesus prophylaxis and albumin solutions for shock and burn victims. CSL Behring AG's production facilities are licensed by the Swiss health authorities and the US FDA. Every year, therapeutically important proteins are isolated from over six million liters of human plasma in accordance with the strictest safety and quality standards and processed into medicines. The products of CSL Behring AG are distributed worldwide.

Working hours

Standard / 41 working hours (6 months)

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 for Site BRN

Qualifikation

Degree in life sciences and/or engineering, Advanced degree (M.Sc. or equivalent) preferred, 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, Efficient, risk-based decision-making in a quality environment, Deep knowledge of GMP and global regulatory requirements, e.g. GMP, FDA, EU and other relevant GxP regulations, Strong communication and influence across all organizational levels, Excellent organizational and interpersonal skills, Effective collaboration with internal and external stakeholders, Experience in project-based work, Fluent in English (spoken and written)