QA Operations Team Lead – Drug Substance
This role will be responsible for leading a team of QA Drug Substance Specialists providing online QA oversight Drug Substance manufacturing operations.
- Lead a team of QA Drug Substance Associates providing QA oversight to technology transfer and commercial manufacturing for manufacturing operations.
- Supervise direct reports on a day to day basis, provide training and communications, assignment and prioritisation of work of direct reports.
- Manage performance, delivery of objectives and career development of direct reports
- Provide QA review and approval of SOPs, risk assessments, change controls and other documentation, as applicable, associated with Drug Substance manufacturing operations
- Ensure that Drug Substance manufacturing operations are conducted according to appropriate cGMP behaviours and compliance to SOPs, batch manufacturing records and other cGMP documentation, as applicable.
- Liaise with Manufacturing Operations to ensure that all deviations, investigations and batch manufacturing records review comments are adequately addressed and closed out in a timely manner as defined in SOPs.
- The QA Team Lead will work with Manufacturing Operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame.
- Liaise with manufacturing operations, QA, QC, Engineering, MSAT etc. in supporting daily operations.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
- As QA Team Lead, you will champion site metrics and KPIs to ensure targets are achieved, met and counter measures in place when applicable,
- Degree in Science, Engineering or similar field of study.
- Strong experience in the biotechnology and/or pharmaceutical industry within a Quality role, preferably in Operations support or similar.
- Experience performing internal audits.
- Experience in supporting Technology Transfer projects would be an advantage.
- Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
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