Description
Pharmaceutical Company based in North Dublin is looking for a validation expert to support operations scale-up including equipment and facility commissioning and qualification.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
- Identify and implement system optimisations where required
- Provide technical input during investigations, gap analysis, risk assessment and change control process
- Provide validation related support to all departments
Requirements:
- Bachelor of Engineering or Science Degree in Engineering or related discipline
- Minimum of 10 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
- Ability to understand project plans and schedules
- Strong written and oral communication skills
- Strong knowledge of GxP
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
To hear more about this excellent opportunity please contact me Anna Mooney .