Description
Scope of Work & DeliverablesManagement and delivery of validation activities at related to the provision of a new Freeze Dryer and associated Vial New Filling Line.
The Capital Projects Validation Lead, reporting to the Capital Projects Validation Manager, is required to provide Project Management and supervision on the following two validation projects:
* New Freeze-Dryer - Project Currently undergoing Post-OQ activities, including development of process cycles, prior to Performance and Process Qualifications.
* New Filling Line Project- This is a recently instigated project; currently at the vendor bidding stage for the Filling Line equipment.
Scope includes, but is not limited to:-
* Working with appointed project team members in the delivery of the project validation strategies including definition of process validation activities to ensure demonstration of product equivalence.
* Generation of Validation protocols including development of System and Component Impact Assessments in accordance with protocols/procedures.
* Participation as validation representative in activities including design review workshops including GMP, SWIFT, HAZOP, Ergonomic, Constructability and Value Engineering.
* Coordination of project validation activities throughout project lifecycle including liaising with Project Management, critical equipment suppliers and designers to ensure validation activities are suitably accommodated within the master project schedule.
* Coordination with Internal and external stakeholders including Subject Matter Experts and MHRA/FDA in relation to project validation status and proposed strategy to introduce facilities/equipment into beneficial use.
Key Skills Needed:
* Extensive knowledge of Full-Life cycle GMP Validation.
* Sound knowledge and experience of 'Risk-Based' approach to validation
* Good experience in management of Validation Projects and supervision of execution of validation activities by multi-disciplinary personnel.
* Familiar with a 'Risk-Based' approach to validation.
* Knowledge of the operation and qualification of the following equipment items used in pharmaceutical production would be beneficial:-
o Freeze-Dryers o Vial Filling Machines
o Vial Depyrogenating Tunnels
o Vial Capping Machines
o HVAC Extract Systems associated with filling lines.
If you are interested or know anyone who might be, please contact myself or Reshma Patel on . We also offer £200 vouchers for any successful referrals.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales