Quality Release Lead (m/f/d)
Michael Page
- Zoug
- CDD
- Temps-plein
- 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.
- 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.