Germany Job Openings
Biosynth
CSV Officer – Quality Systems
Berlin
FULL TIME
October 11, 2024
We acknowledge the important part our team members, who are based over three continents, play in our continued success.
Overview:
Biosynth is seeking an experienced CSV Officer for our Quality Systems. This position will be based out either our Leicester (UK), Lelystad (Netherlands), Staad (Switzerland) or Berlin (Germany) sites. 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.
Role and Responsibilities:
- Lead and manage ongoing and new CSV runs for our quality systems for SAP, e QMS, Laboratory Information Management System, Electronic Laboratory Notebook in our CSV Team
- Develop, implement, and oversee quality system requirements for ISO and Gx P.
- Conduct and supervise regular audits and inspections of regulatory inspections and authorities.
- Ensure compliance with industry standards, regulatory requirements, and company quality objectives.
- Drive investigations into our quality systems and necessary infrastructure
- 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.
- A degree in Biology, Chemistry, Biochemistry, or a related field. Advanced degree is preferred.
- Extensive experience in a CSV Officer role, specifically in the life sciences or pharmaceutical industry.
- Proven leadership skills with experience managing and developing a team.
- In-depth familiarity with quality standards and regulations (e.g., ISO, c GMP, FDA).
- Demonstrated success in managing audits and maintaining compliance with regulatory authorities such as the EPA, USDA, FDA, and other relevant organizations.
- Exceptional analytical, strategic planning, and problem-solving skills.
- Outstanding communication and interpersonal skills.
- Proficiency in Microsoft Office, quality management software.
- Experience with M-Files, LIMS systems, ELN and SAP is highly beneficial.
- Ability to work independently and collaboratively, managing multiple priorities in a dynamic environment.
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.
Biosynth, is proud to be an equal opportunity employer. We value diversity and are committed to creating a workplace that reflects this commitment. 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.
Job Types: Full-time, Permanent
Location:
- 13125 Berlin (Required)
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