The Senior Specialist will support the start-up of a commercial drug product manufacturing facility for biologic’s commercial portfolio and clinical pipeline, providing quality assurance oversight during project design, construction, and qualification phases.
a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, life assurance and on-site gym
- Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and AVI.
- Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
- Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.
- Support CQV / Tech Transfer / Operational Readiness activities including New Product Introduction, SOP Development, Training Material development, MES / MBR Design, and CQV support.
- Develop and execute training programs in support of multiproduct manufacturing.
- BSc in Science or related discipline
- Nice to have: Detailed knowledge of Sterile Drug Product
