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Imp Quality Manager
vor 3 Monaten
**INTRODUCTION**:
As Preferred Supplier for Roche Basel we are looking for a committed personality as
**IMP Quality Manager (M/F/d)**:
- (contract for one year with possibility of renewal by mutual agreement) with start date within one month. Home Office possible 60% onsite required.
**ASSIGNMENT DESCRIPTION**:
- responsible for the lot disposition of IMP e.g. bulk drug product materials and active pharmaceutical ingredients (API)
- ensures that the quality of the produced IMPs, manufactured by Technical Research and Development (TR&D) Basel, is in accordance with cGMP regulations
- actively participates in compiling, reviewing and approving of Roche Pharma Quality System(PQS) standards
- reviews and approves documents, e.g. Production Records, methods and specifications, change control documents, risk assessments, deviations and investigations
- participates in internal as well as in external audits
- In the role of Q-SPOC you:
- act as a single point of contact for the Technical Development Teams for Early State Products
- lead the Quality Sub Team consisting of all IMP relevant QA functions are responsible to identify and communicate significant quality risks as well as to drive risk mitigation plan
**REQUIRED PROFILE**:
- Master degree or PhD in Life Sciences or similar degree
- Minimum 5 years of relevant experience in the pharmaceutical industry
- Demonstrated experience in a Pharmaceutical Technical Development environment (Small or Large Molecules or New Modalities)
- Knowledge of cGMP and Quality requirements for clinical development stages
- Strong leadership, communication and influencing skills
- Ability to communicate clearly and professionally both verbally and in writing in English as well as in German
**Application process**: Interested? You can find more information here: