Description
Activities:- Preparation and review of documents associated with lifecycle of C&Q activities including Risk/Impact Assessments, DQ, IC, OC, IQ, and OQ.
- Work on a team to support development and execution of C&Q deliverables - DQ, Impact Assessment, IQ and OQ for a range of medium / large projects.
- Co-ordination of the compilation of handover documentation packs to demonstrate compliance with the installation / verification processes/procedures on site.
- Coordination and attendance at walk-rounds (Mechanical and E&I), projects and operations staff to review and sign-off installation works carried out by the projects group.
- Proved experience in safe operation of the system prior to and during start-up functional testing, Operational Verification - System Startup activities, Functional Testing of systems.
- Change Management activities during project lifecycle and Protocol/Report writing.
- Hands- on experience of the start-up and on-going operation of process and utility systems or equivalent high spec environment.
Experience:
- At least 5+ years experience in Validation and or Commissioning in Pharmaceutical Industry.
- Degree qualified in Engineering or relevant Technical discipline.
- Good general knowledge on Quality, cGMPs, ICH and ISO guidelines as well as experience on their application;
- Strong Technical Knowledge of Project Engineering applied to Process equipment, facilities, utilities and HVAC systems
- Formalised Training in Risk Assessment/Analysis techniques
If you are interested in this position please contact me on or reply with a copy of you CV.
We offer shopping vouchers for any successful referrals so if you know of anyone who would be suitable for this position please get in touch.