Validation Manager - Life Sciences - Permanent - South East, UK
Adepto brings you this exclusive vacancy on behalf of our leading life science client. Our client is a true leader in the biopharmaceutical sector and they are seeking a Validation Manager to lead their validation group. This is an exciting opportunity to have a real impact and impart your knowledge, leadership and experience to the team and wider organisation
About you!
* Applicants must be degree qualified and demonstrate strong knowledge of GMP with previous experience working within pharmaceutical or biopharmaceutical manufacturing.
* Manage people within the team and provide leadership.
* Author and execute validation protocols.
* Write validation procedures including VMP.
* Operate independently and work collaboratively within small teams across departments.
* Plan and prioritise varying and high volumes of work for the team.
* Organise daily workload and meet agreed deadlines and support longer term projects.
About the role!
* Manage the day to day activities of the Validation team and development and performance of direct reports on a day to day basis; interact with many different functions and levels within the organisation.
* Responsible for coordinating and supporting validation activities.
* Co‑ordinate and perform validation project activities for all facilities, equipment and processes operated in compliance with EurdraLex Volume 4 – Good Manufacturing Practice (GMP) guidelines requirements and other applicable quality system requirements.
* Establish and maintain best practices for departmental procedures to ensure effectiveness to validation requirements.
* Provide direction and expertise in the management of validation activities.
* Prepare, execute and report validation protocols.
* Rationalise validation documentation (and protocol requirements) to ease routine validation activities while validation requirements are met.
* Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner with minimal disruption to production.
* Maintain an awareness of regulatory developments in the validation field and brief Operations personnel as appropriate.
* Attend meetings, both internal and external, representing the department in a professional manner.
* Ensure review and update of validation procedures (Policies, Master plans, Standard Operating Procedures (SOP's) etc.) for equipment and facilities.
* Participate in audits by customers and regulatory authorities.
* Sign as proxy for all direct reports within the Validation Department, as needed.
* Demonstrate commitment to the development, implementation and effectiveness of the Quality Management System per MHRA, FDA, ISO and other regulatory agencies or standards.
* Support Environmental Management System (EMS) activities and compliance per ISO14001.
* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
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