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Qc Project Manager
vor 3 Monaten
Are you experienced in biopharmaceutical process development of Drug Products? And now you want to leverage your knowledge to the next level.
Duration:
end of 2024 (extension most likely)
Main responibilities will be:
- Acts as the technical and administrative QC project lead in complex, longterm DP projects.
- Supports the QC (OOS/OOE etc) Deviation and CAPA processes specific to their assigned customers; reviews and review investigation report
- Participates in the initial assessment of new products and processes.
- Provides input to program management regarding QC capabilities and requirements for method qualification/validation. Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
- Provides QC representation to DP site and project team meetings.
- Writes, reviews, and/or approves Test Records/Forms, Sampling Plans, and Specifications.
- Leads tech transfer activities related to QC
- Works in cooperation with QC Services to design qualification, and validation protocols.
- Coordination with testing sites Lonza Basle, Stein, Visp and external Service providers.
Your ideal background is:
- Higher degree in biotechnology or related field with significant experience in a biopharmaceutical environment.
- Practical and scientific expertise in DP relevant areas.
- Expertise in early and late phase process development.
- Proven leadership skills to motivate and develop team members.
- Experience with method validation and technology transfer required
- Knowledge of SAP and TrackWise systems a plus
