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. Applicants must also have the ability to;
- 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
Salary description
£65000.00 - £70000.00 per year