Technical Support Specialist

- Investigate deviations, working closely with manufacturing staff, and recommend robust CAPAs to prevent reoccurrence. - Ensure timely disposition of all material in QT relevant to assigned area. - Assist in identifying the root cause of deviations and collaborate with the manufacturing team to develop CAPAs. - Liaise with the production team to generate necessary documentation (Validation protocols, reports, PCRS). - Work with cross-functional teams to ensure documentation reflects the manufacturing process accurately. - Assist in validating new and existing equipment and processes, ensuring compliance with GxP standards. - Raise necessary change controls to prevent impact on production schedules. - Collaborate with other departments to ensure change control meets requirements and support timely closure of existing change controls. - Support production team in Compliance Excellence initiatives to ensure adherence to GMP and customer requirements. - Facilitate effective staff development and training through SOP updates and change controls. - Maintain a robust database of production-related consumables to ensure availability and compliance with cGMP standards. - Provide occasional out-of-hours support due to operational flexibility requirements.