We are delighted to be supporting a leading organisation based at Porton Down Science Park, who are looking to recruit an experienced Validation Manager to join their growing business.
In this role you will be responsible for ensuring that all equipment, facilities, processes and systems used in the manufacturing and testing of products have been appropriately validated and maintained in a validated state.
Main responsibilities include:
Responsible for driving all aspects of Validation Life Cycle.
Develop and maintain the Validation Master Plan ensuring it reflects current practices.
Define and optimise the overall validation strategies, policies and programs. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations.
Manage the development and execution of validation protocols for all facility services, utilities, equipment and systems including computer systems involved in regulatory processes. Manage the development and execution of the equipment cleaning validation program. Oversee the validation of laboratory equipment and method validation.
Manage the development and implementation of a validation maintenance program which periodically reviews the status of validated systems.
Interface with appropriate regulatory inspectors on all validation issues and present the validation program in regulatory audits.
Manage the validation group. Support the development plan for validation activities. Set priorities for self and staff within the guidelines set by supervision.
Responsible for determining the need for identifying, contracting, and managing the efforts of outside consultants and contractors when necessary to maintain the facility validation program compliant with regulatory requirements.
Determine project resource requirements for engineering/ validation including capacity/ capability. Where required assess, appoint, control and direct specific Contractors and Suppliers.
Responsible for QMS compliance of validation.
Person Specification:
Holds a Bachelors or Masters Degree in an applicable discipline or equivalent practical experience in a similar role.
Minimum of 5 years’ experience working in the pharmaceutical industry.
Able to demonstrate practical experience of the operation, commissioning and validation of equipment, utilities and facilities used in the manufacture of pharmaceutical products.
Experience of working within a GMP Quality System.
Able to demonstrate excellent communication skills as main point of contact for engineering issues to stakeholders.
Have current right to work in the UK.
If this role sounds of interest to you, please contact Carrie today or click apply!