Senior Quality Assurance Auditor (Germany)

Company Description:

IPM Biotech, a subsidiary of BioAgilytix, is a contract research organization (CRO) in Hamburg, Germany that offers fully integrated bioanalytical laboratory services to support every stage of biologics development from early discovery through pre-clinical studies and clinical phases I, II, III and IV including custom assay development and validation and sample analysis as well as drug release testing. As a GLP, GCP/GCLP and GMP bioanalytical lab facility, IPM Biotech supports product releases of biologics, biosimilars, and biobetters.

Position Description:

The principal responsibilities for this position are to:

  • Lead/conduct routine, in-phase, process, facility, vendor and computer/equipment systems audits and inspections
  • Write and issue audit reports and review responses to audit findings for appropriateness and completeness
  • Write and review Standard Operating Procedures
  • Maintain documentation and status of auditing activities
  • Assist in educating, guiding and influencing management and staff on best quality and compliance policies
  • Support regulatory and sponsor audits

Requirements:

  • Degree in biology, chemistry, or other scientific or related field with a minimum of five (5) years of experience in pharmaceutical / biotechnology / CRO preclinical / clinical quality assurance operations
  • Experience hosting regulatory/sponsor audits
  • Solid understanding and up to date knowledge of FDA and EPA GLP regulations, OECD Principles of Good Laboratory Practice, FDA GMP regulations and industry standards as they apply to the life sciences and pharmaceutical industries
  • Ability to work in a fast paced environment where multiple projects are in process and must be completed in a timely manner under minimal supervision
  • Proficient use of computer and Microsoft software programs
  • Fluency in English is required
  • Fluency in German is desired
  • Excellent oral and written communication skills and attention to detail

Benefits /Future Perspectives:

  • International working environment
  • Attractive salary
  • Bonus program
  • Professional training opportunities

Are you interested? We are looking forward to receive your application in English. Please submit your complete application and include your salary expectations and earliest start date.

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