Quality Assurance Manager
Vor 6 Tagen
This role involves overseeing the entire quality systems, creation and updating our CSV and maintaining compliance with industry standards ISO and GMP. The CSV Officer will be a part of our global quality team and will also oversee our CSV Team playing a pivotal role in strategic planning for our quality systems.
Key Responsibilities:- Lead and manage ongoing and new CSV runs for our quality systems for SAP, eQMS, Laboratory Information Management System, Electronic Laboratory Notebook in our CSV Team
- Ensure compliance with industry standards, regulatory requirements, and company quality objectives
- Analyze data to develop strategies for continuous improvement in the quality system
- Manage regulatory compliance issues, including preparation and execution of audit plans
- Facilitate international collaboration with other global Quality Unit teams for global quality assurance consistency
- Coordinate with production and QC teams for compliance and quality improvement initiatives
- Develop and implement training programs for quality assurance and compliance for staff
- Ensure ongoing adherence to local, national, and international standards and legislation
- Demonstrated success in managing audits and maintaining compliance with regulatory authorities such as the EPA, USDA, FDA, and other relevant organizations
- Proficiency in Microsoft Office, quality management software
- Experience with M-Files, LIMS systems, ELN and SAP is highly beneficial
Biosynth is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland. We are by scientists, for scientists, securing supply chains with consistent quality, across the globe. As a trusted supplier, manufacturer and partner to the pharmaceutical, life science and diagnostic industries, as well as food, agrochemical and cosmetic customers, we have facilities on three continents and a rapid global distribution network. Our main production laboratories are located in Switzerland, the UK, Slovakia and China, with peptide and antibody production in the US, the UK and the Netherlands. Enzyme projects are based in Austria, bioconjugation projects in Germany and biological IVD reagents in Ireland.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.
Recruitment agencies - We do not use external recruitment agencies to recruit for any of our positions. We will not accept unsolicited CVs and communications from external recruiters.
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