Description
Equipment validation lead required to join a global pharmaceutical company in the south west UK. An initial 12 month contract to start ASAP the equipment validation lead will be required to lead the team and ensure the qualification of new equipment on site.Role and Responsibilities:
Generation, execution and review of all life cycle validation documentation for the qualification of equipment.
. Autoclaves
. Parts Washers
. Vessel Systems
. Filling Machines
. Vial Washers
. Depyrogenation Tunnels
. VHP Transfer Devices
. Clean In Place systems
. Clean Out of Place Systems
. To ensure that all documentation is prepared, authorised and completed in a timely manner.
. To supervise work of those undertaking validation activities
. To ensure that all tasks are carried out in an effective and efficient manner.
. To liaise with the various departments involved in the qualification and validation work to ensure the efficient performance of the related tasks.
. To maintain an understanding of current international regulatory, ISO, corporate and client requirements relevant to the section. To ensure compliance with the sections and site procedures.
. To communicate effectively with others on site and the client associated with the project.
. To assist in the investigation of problems and provide support to the business in resolving quality issues
. To ensure that adequate training has been received and documented
. Comply with GMP requirements and company rules, policies and procedures.
Qualifications/Experience:
. Significant demonstrable experience of equipment qualification
. Higher level qualification preferable
. In-depth knowledge and understanding of cGMP.
. Self-motivated, with a pro-active approach to taking on challenging assignments.
. Previous experience of applying V model approach to validation activities
. Creativity, judgment and analytical thinking.
. Ability to work with critical timelines.
. An excellent planner, who can envision short-term milestones to succeed in the long-term.
. Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
. The drive and maturity to lead combined with the ability to support and interface effectively with projects and motivate cross-functional teams.
If this is you please apply today