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CMC Regulatory Affairs

Switzerland   •  CHF40 - CHF45 per hour  •  Contract/Temporary, Full time


Description:

As expert, you are supporting the release and stability strategy, the method validation and method transfer activities for our products covering development activities.
You will support the operational aspects of GMP testing of Biologics clinical drug substances (DS) and drug products (DP). You independently manage your activities and provide required documentation according to agreed timelines and standards.

Major Accountabilities:

  • Responsible for the successful delivery of work packages to support GMP testing of Biologics clinical drug substances (DS) and drug products (DP) for release/stability/validation/transfer
  • Author and/or review of technical source documents in accordance with project timelines for global submissions.
  • Review high-quality CMC documentation for HA submission.

Minimum requirements:

  • Well-developed planning, organizational, problem-solving and interpersonal skills.
  • Good communication skills with a collaborative and patient-focused mindset
  • Computer/IT systems literacy

Desirable requirements:

  • Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired.
  • Minimum 2 years of Quality Control experience in a GMP environment and/or pharmaceutical industry experience.
  • Sound technical and scientific knowledge of pharmaceutical development and analytical sciences.
  • Knowledge on health authority regulations.
  • Proven ability to critically evaluate data from a broad range of scientific disciplines.
  • Proficient in English (other languages are a plus).

For more information, please contact Fandi Hatib on +44 1727 817 600 or email fhatib@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: 34806
  • Posted: 11th May 2022
  • Expires: 8th June 2022

Achieva Group Limited

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