Reports to Associate Director QA Change Control.
Change Control activities include:
- Position will involve assessing, reviewing and progressing change control documentation from all areas on site as part of a cross-functional team.
- Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision while ensuring communication to area leadership.
- When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, while considering operational impact to the site.
- Review change control documentation for clarity, ensuring relevant supportive data has/ will be generated.
- Confirm categorisation of change in accordance with site and Global procedures
- Collaborate with site Change Owners, SMEs, and CMC to determine impact to Clinical / commercial licenses for proposed changes.
- Provide Change control support as required during HA inspections
- Provide change control training to the site in accordance with procedures
- Share best practice with the team and the network
- Carry out annual product reviews from Change Control Perspective
- Any other tasks as deemed necessary to support the change control function
Qualifications:
- Degree in biochemical/ biomechanical engineering or equivalent. Advanced degree preferred
Experience:
- Years operations experience -Regulatory / Technical / QA experience in a manufacturing operations environment and/or support function or equivalent.
- Equipment / validation / C&Q / software engineering experience desirable
- Project management skills
