The Validation Manager will manage, plan and execute adherence to the Validation Master Plan which includes process validation, analytical method validation, equipment qualification, cleaning validation, computer system validation and validation of facilities and utilities. Responsible for leading a team with responsibility for validation activities associated with manufacture of drug products, medical devices and device/drug combinations
Responsible for ensuring that the site is fully compliant with the regulatory requirements as they relate to validation/verification and qualification of systems, processes, methods and equipment in device and drug manufacture.
Develop and implement validation policy. Develop a validation strategy in line with the requirements set out in ICH Q10, “Quality Risk Management”.
Manage, coordinate and guide the execution of the overall site validation master plan. Maintain a system for tracking the validation documentation hierarchy. Maintain a system for storing all validation documentation through the validation lifecycle. Review and approve validation documentation as required, including, but not limited to, commissioning/qualification test scripts, validation protocols, summary reports and risk assessments.
Manage the validation team and ensure that all projects are on schedule and meet the required timeline. Develop members of the validation team to ensure appropriate levels of training, competence and capability. Execute a succession plan as part of the program for personnel development. Contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external customers.
Lead validation projects and complete all associated project documentation in line with quality and regulatory expectations. Participate in periodic reviews during product life cycle to deepen process performance understanding and drive process improvement. Participate in quality management reviews as a representative of the validation team.
Provide oversight and validation expertise during the development of new product and new technologies. Act as the point of contact during regulatory inspections for discussions relating to validation activity.
Develop and maintain key performance indicators for monitoring the site validation program. Effectively monitor and communicate the validation projects execution plan to other departments, project managers and key stakeholders. Develop validation templates where possible, to improve performance and efficiency where possible.
Ensure compliance with environment, health and safety rules, signage and instructions.
Ensure that all subordinates are suitably trained to carry out their roles effectively and assist in the co-ordination of their training programme.
Education & Qualifications
BSc (or equivalent) in Engineering, Scientific or similar discipline.
A minimum of 5 years’ experience in a similar role within the medical device or pharmaceutical industry.
Experience of design controls related to developing and verifying/validating products.
Proven track record of people management and development.
CVs to John Phillips at john.phillips@RFTgroup.ie