Description
Responsibilities/Tasks:- Write, review, approve and execute commissioning and qualification documents (equipment and facility)
- Plan validation project schedules and prioritize validation activities in line with schedules and overall technology transfer priorities
- Attend and sign-off on equipment FATs
- Attend and sign-off on construction walk downs
- Manage the vendor representatives in the field during commissioning/qualification
- Managing the preparation of equipment test runs
- Execution of testing and the SAT/IOQ documents onsite
- Complete review of vendor & construction docs to support commissioning and qualification activities
- Ensure non-conformances and deviations are minimised and closed out in a timely manner
- Attend project meetings with senior management and report progress
- Supervision of contractors/vendors during commissioning
- Preparation of commissioning and qualification summary reports
- Manage commissioning and qualification of equipment and facility
Requirements:
- Bachelor of Engineering or Science Degree in Engineering or related discipline
- Minimum of 7 years' experience in the Pharmaceutical Industry in a validation role
- Experience working in a solid oral dose environment
- Experience in preparation & sign off of SAT and qualification (IO/OQ) documentation
- Experience in managing commissioning and qualification projects
- Experience of both equipment and facility qualification
- Excellent attention to detail and good documentation practices
Desirable:
- Process validation experience (including protocol write up and execution).
- Process scale-up and optimization for manufacture of clinical and commercial products.
- Experience in technical transfer of specified unit operations to contract manufacturers and supporting external process scale-up activities.
- Computer systems validation experience
Please contact Sarah Irvine on or reply with an updated version of your CV. We also offer shopping vouchers for any successful referrals so please get in touch if you know of someone who would be suitable.