Job Title:
Senior Quality Assurance Specialist
The Senior Quality Assurance Specialist will be responsible for ensuring adherence to safety standards and SOPs in all activities. This includes reviewing and approving production batch records and associated documentation for Qualified Person disposition activities.
Additionally, the successful candidate will provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
This role also involves conducting inspections of vials and syringes as part of AQLs, annual reserve inspections, and supporting complaint investigations.
* Ensure adherence to safety standards and SOPs in all activities.
* Review and approve production batch records and associated documentation for Qualified Person disposition activities.
* Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
* Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
* Offer Quality Assurance support for on-the-floor investigations and deviations.
* Review and approve deviations for closure, ensuring compliance with appropriate documentation.
* Participate in customer complaint investigations.
* Conduct routine Quality Assurance walks on the production floor.
* Review and issue logbooks, ensuring compliance with procedures.
* Provide training and guidance to staff for effective performance.
* Review and approve cGMP records, ensuring compliance with appropriate documentation.
* Support continuous improvement and Operational Excellence initiatives.
* Undertake other tasks/projects as assigned by the manager.