Hobson Prior are seeking a Validation Manager to join a leading provider of advanced technologies and services for the pharmaceutical, biotechnology and consumer health industry. This role will be accountable for managing and coordinating all required Validation activities and associated documentation.
- Manages and coordinates all Validation activities associated with new/existing equipment qualification, PPQ, Cleaning Validation and Continued Process Verification.
- Upholds current SOPs associated with the Validation Department and Validation Master Plan
- Acts as the site subject matter expert for all validation related items during internal client, external client, corporate and agency audits.
- Reviews site Validation documents and procedures. Maintains them in a current state with all corporate, cGMP, ISPE, GAMP, ICH and current Industry Standards (MHRA / FDA)
- Represents as the project Validation Lead for all site facility expansions. Includes developing Scope, Schedule and Budget for associated validation activities. Maintains relationships with consultants/vendors and internal clients for the coordination of activities and qualification of all items.
- Reviews and approves site Validation Master Plan.
- Generates protocols and reports for equipment and facility qualification, PPQ and Cleaning Validation, as required. Ensure documents are in accordance with the current site and corporate Validation SOP’s and guidelines.
- Support investigations of manufacturing / facility deviations, as needed.
- Completes Validation Technical Review on all site-wide Change Controls.
- Excellent computer skills.
- Able to manage people, priorities and projects prioritizing effectively. Must communicate clearly.
- Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Microbiology, etc.).
- Minimum of 10 years of experience within the pharmaceutical or medical device industry with emphasis in Validation or Quality areas preferred.
- Demonstrated capacity for sound decision making and professional judgment.
- Knowledge of current Validation expectations and GMP requirement to meet EU and US regulations.
- Experience of Cleaning validation, CSV, Data integrity, EU V4 Chapter 5, Annex 11, Annex 13, Annex 15.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.