• To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Quality and best practice requirements.
• To develop and implement the companies validation philosophy and approach.
• To develop and implement the Validation Policy, validation framework and holistic Validation Master Plan (VMP) across the business
• To develop and implement the companies validation standards and standard operating procedures.
• To generate and maintain the company VMP to ensure all facility, equipment, process, utilities, analytical methods, cleaning and computerised systems are qualified in compliance with regulations and standards, and specifically with GMP.
• To provide technical expertise and guidance in validation approach and documentation as relating to Business Units (BUs) and Grand Challenge (GC) team.
• To work with the Business Units (BUs), Grand Challenge (GC) teams and Quality Validation Specialists, adopting a risk management approach, to define the overall validation strategy for each of the BUs / GCs.
• To support and guide the BU validation managers and GCs with validation and qualification activities associated with any new facility design & build, including utility systems, the establishment of the process equipment, and with ongoing operations
* Educated to Degree level (or equivalent) in a science/engineering subject plus significant industrial experience within a GMP manufacturing environment.
* In-depth experience of operating at an expert level. Will possess significant quality validation expertise and experience of operating within a senior operational role within a GMP environment, developing and implementing validation programmes.
* Can demonstrate evidence of building crossindustry and organisational knowledge sharing and network building. Expert knowledge of GAMP, GMP Guidelines EU GMP Annex 11 and Annex 15, 21 CFR Part 11.
* Experience of providing support for internal and external audits. Practical knowledge and experience of cGxP requirements for Pharma manufacturing plants. All aspects of facility, equipment, computer systems and laboratory validation.
* On time delivery of technical and operational objectives Managing and exceeding customer expectations Experience of providing support for internal and external audits