CQV Manager Job Description
The ideal candidate for this role will be responsible for leading and coordinating CQV project activities in line with the site project strategy. They will work closely with various project functions to understand their functional requirements and develop an optimum validation strategy.
Main Responsibilities
* Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
* Support and coordinate the transition to a digitized C&Q platform.
* Ensure effective resource planning is established and managed throughout the project.
* Manage and coordinate equipment qualification activities, including Factory Acceptance Testing (FAT), SAT, DQ Installation-Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
* Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
* Manage and coordinate all CQV documentation to support CQV activities.
Required Skills and Qualifications
The ideal candidate should have experience in the deployment and/or extensive working knowledge/experience of a digitized C&Q platform, such as Kneat Solutions. They should also have a clear understanding and previous experience in deployment and execution of a Risk-Based Validation (RBV) process in line with ISPE guidelines.
* Experience in managing teams or projects in a fast-paced and complex environment.
* Relevant qualification (Degree) and/or relevant experience of 10+ years in biotech/pharmaceutical industry qualifying GXP systems.
* Significant project lifecycle experience in delivering CQV projects for Capex projects.
* Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.
Benefits
This role offers the opportunity to work on high-profile projects and collaborate with cross-functional teams. The ideal candidate will be a strong communicator, team player, and dynamic decision-maker who can effectively plan, coordinate, and execute CQV projects.
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