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A new vacancy has arisen within a leading pharmaceutical organisation for a Validation Lead to join them on a permanent basis in Stevenage. Our client is committed to providing life-changing therapies that can be developed for use in health services throughout the world. This role will oversee the overall site validation strategy and perform validation activities associated with the organisation's manufacturing centre.
- Accountable for the maintenance of critical facility and laboratory utilities qualified state: HVAC, EMS, medical gases, GMP environments, VHP sanitising equipment.
- To establish the qualification strategy for new utilities/systems /environments etc.
- Data integrity compliance strategy and execution (although no overall Computer Systems Validation responsibility).
- Periodic review (requalification).
- Management of planned and unplanned change (Change Control & Deviations) as they impact qualification status.
- Accountable for authoring, executing, and reporting validation activities within the framework of cGMP - Annex 11 & 15 and in compliance with the organisation's PQS requirements.
- You will be expected to represent Validation during internal and external audits and inspections (by both regulatory authorities and collaborator organisations).
- You will be required to manage multiple validation projects, liaising with the project teams and all associated departments on site relating to the validation objects and ensuring work is completed in a timely manner.
- Ability to evaluate complex situations and find solutions for them in a professional manner.
- Able to take initiative and work independently; sense of urgency in completing assigned tasks.
- Having a passion for delivering excellent customer service in a cost-effective way.
- A good team player, with strong organisational skills
- Flexibility towards work assignments and new learning.
- Excellent interpersonal, written, and verbal communication skills.
- Accurate with a strong focus on attention to detail.
- Having current and up to date professional knowledge, expertise, and best practice.
- BS or MS degree in life science or engineering discipline; knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP/EA/MHRA policies/guidelines).
- Member of a recognised professional body is admirable.
- Highly methodical and organised, including time-management skills and changing priorities.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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