Quality Release Lead

vor 3 Wochen

Zug, Schweiz Michael Page Vollzeit

The selected candidate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance with the requirements of the marketing authorization and with good manufacturing practice, by carrying out the following task areas:

  • Reviews and verifies batch release documentation according to local procedures and product specific checklist.
  • Prepares and approves the certificates of conformance and market-specific release documentation.
  • Checks quality-relevant status changes of the inventory in the client's systems
  • Influences the strategy of the manufacturing of their products at the CMOs and to sustain without disruption of the supply chain.
  • Contributes to launches, commercialization, technology transfer or improvements projects through release process adjustments.
  • Collects and performs KPIs analyses including feedback from other departments (for example planning).
  • Manages stakeholder and delegates for the release activities through SME assessment and decision making.
  • Identifies and drives improvements/updates of the GMP documentation related to release activities and CMO oversight from release perspective.
  • Identifies any compliance gap in the client's processes and identifies appropriate stakeholder to fix the issue.
  • Supports local quality system (change control, deviations, CAPAs, …) as required.
  • Ensures adherence to serialization and data integrity requirements.

In order to be considered for the role, the selected candidate must have:

  • Successfully completed bachelor's and/or master's degree in a scientific field (Pharmacy, Chemistry, Biology, Biochemistry etc)
  • Minimum 6 years' working experience within a similar role in the pharmaceutical or biotechnological industry.
  • Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling)
  • Solid knowledge of cGMP requirements, EU/FDA regulations and compliance.
  • Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
  • Ability to develop effective working relationships with internal/external sites and cross-functional project teams.

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