GMP Validation Manager

Zoek Pin Salisbury, Wiltshire, England

Permanent (Full time)

Recently Posted

GxP Recruitment invites applications on behalf of our biopharmaceutical client in Wiltshire where an excellent opportunity exists now for a Validation Manager to join their team on a permanent basis.

Key duties include:

* 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.

* Develop and optimise overall validation strategies, policies and programs

• 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

The ideal candidate:

* Degree qualified in scientific or engineering discipline

* Experience in leading a validation team

* Previous knowledge of biopharma processes and/or validation life cycle documentation

* Experience of dealing with internal customers

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