CSV Systems Manager

vor 3 Wochen

Berlin, Berlin, Deutschland Biosynth Vollzeit
Job Title: CSV Systems Manager

Biosynth is seeking an experienced CSV Systems Manager to oversee the quality systems and ensure compliance with industry standards ISO and GMP.

Key Responsibilities:

  • Lead and manage ongoing and new CSV runs for our quality systems
  • Develop, implement, and oversee quality system requirements for ISO and GxP
  • Conduct and supervise regular audits and inspections of regulatory inspections and authorities
  • 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

Requirements:

  • A BSc 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
  • Demonstrated success in managing audits and maintaining compliance with regulatory authorities

About Biosynth:

Biosynth is an innovative life sciences reagents, custom synthesis and manufacturing services company headquartered in Staad, Switzerland.

We are an equal opportunity employer and value diversity. 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.

We are committed to creating a workplace that reflects this commitment and to providing a work environment free from discrimination and harassment.

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