Deine Übereinstimmung

Skills

CommunicationGxP complianceQuality assuranceCollaborationLife SciencesProject management softwareGood Manufacturing Practice (GMP)Risk-based PlanningRegulatory Compliance in MedicineInterpersonal communicationEU directivesFDA

Sprachen

Englisch

Die Stelle

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)

01Execute GxP supplier qualification activities,

02Lead vendor qualification including document review and audit execution,

03Ensure qualification of vendors providing GxP-relevant equipment and services,

04Act as Quality Delegate / Change Coordinator for Vendor Qualification Change Controls,

05Establish and Maintain Overview of already Qualified and to be Qualified Vendors for Site BRN

Anforderungen

↳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)

Vorteile

Unternehmen

We make it GmbH

Pharmaceuticals

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.

Kontakt

Mr. Raphael Sigg

Vendor Qualification Associate for CSL Behring in Bern