Quality Assurance Manager

vor 1 Woche


Kaiseraugst, Schweiz Solvias AG Vollzeit
  Quality Assurance Manager Company information
Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell&Gene Therapy and Cosmetic industries. With headquarters near Basel, Switzerland, over 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster. Do you have an eye for detail and a passion for quality assurance? Teamwork is not just an empty phrase for us and we give you the opportunity to make a difference. Does that sound good? Then we might have the right offer for you. Our team at our Kaiseraugst site is looking for an experienced professional in quality assurance and is looking forward to getting to know you. Your tasks
  • Review and approval of SOP's, protocols, reports, Certificate of Analysis and other quality documents
  • Support quality investigation of deviations and Out of Specification (OOS)
  • Maintenance, recording and processing of corrective and preventive measures (CAPA)
  • Performing internal audits
  • Organization and management of customer audits, and inspections
  • Apply and interpret audit and compliance requirements
  • Act as QA point of contact for customers
  • Support for GMP training
Requirements
  • Scientific education (Master degree) in analytical chemistry/ biochemistry/ life science
  • Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment preferably experience in QA
  • Strong problem-solving skills to meet business objectives
  • Excellent interpersonal skills and teamwork spirit
  • Ability to collaborate in a dynamic, cross-functional matrix environment
  • Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
  • Solid background in data integrity and computerized systems risk assessment and project support
  • Experience as an auditor is an asset
  • Fluency in English and wiliness to learn German is required
  • Flexible work models such as part-time and remote work
  • Minimum 28.5 vacation days
  • Monthly child allowance above the Swiss minimum
  • Voluntary monthly family allowance
  • Various pension fund solutions
  • Daily allowance insurance and non-occupational accident fees paid by Solvias
  • Reka cheques
  • Commuter contribution for using public transport
  • Employee discount programs for fitness, insurance, retail and more
  • Onsite canteen
    Our employees are very close to our hearts. Each individual can make a difference and develop both professionally and personally. Does this appeal to you? We are looking forward to receiving your online application. Apply now   © SOLVIAS AG jid56cbca7a jit0101a

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