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Life Sciences Stellen Basel

Senior Quality Manager (m/f), 100%

Temporärstelle
Einritt: by arrrangement
Region: Basel
Stelle: Life Sciences
Art: Temporärstelle

Pharmaceutical company needs reinforcement.

by arrrangement

Our customer, a pharmaceutical company based in Basel, needs reinforcement. For a temporary employment (duration: 1 year) we are looking for a

Senior Quality Manager (m/f), 100%

Aufgaben

Job Purpose

  • Provide QA oversight on all external suppliers. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management.

Tasks

  • Responsible for initiating and driving supplier qualifications
  • Upgrade of supplier qualifications from clinical to commercial in scope of going commercial project
  • Upgrade of raw materials and consumables from clinical to commercial in scope of the going commercial project
  • Oversight on all suppliers and raw materials used
  • Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
  • Manage and evaluate change notifications from external suppliers
  • Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
  • Perform local implementation of Quality Manual and global procedures (gap assessment, local changes in SOPs…)

Anforderungen

Requirements

  • Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
  • Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
  • Fluent in English (oral and written) required; fluent in site-language desirable
  • At least 3 years of relevant experience.
  • Strong ability to negotiate and communicate.
  • Good team working skills
  • Sound scientific, technical and regulatory knowledge.
  • Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
  • Good knowledge of drug development and drug substance production.
  • Good organizational skills.
  • Good and proven ability to analyze and evaluate GMP compliance.

Für Fragen

In case of any question, please don’t hesitate to contact Renato Imboden at 061 269 90 60.

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