To maintain the qualification & validation status of processes and systems in support of new, transferred, and existing products through definition & maintenance of contemporary methodologies & standards.
- The QA Head of Validation is the owner of Qualification and Validation of existing (operational) equipment, systems, products and processes (manufacturing, packaging and cleaning).
- Management of the Qualification / Validation Group
- Responsibility for the Qualification and Validation “system” and methodology
- Responsibility for the Site Validation Master Plan
- Responsibility for planning, coordination, execution and follow-up of qualification and validation activities
- Accountability to the Technical Committee for periodic updates on performance against Site VMP
- Contribution to maintaining and periodically evaluating the qualification/validation/part11 status of equipment, systems, products and processes
- Spokesperson during internal and external audits for qualification/validation of “operational” equipment, systems, products and processes
- Responsibility for the qualification/validation budget including costs charged to projects / clients
- Responsibility (indirect) for Qualification of laboratory equipment
- Close link with the functions responsible for qualification/validation of analytical methods
- Active involvement in the introduction of new products, new processes, new equipment and new systems
- Understand and ensure implementation of emergency procedures and safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
- Science based degree
- Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.’
- Professional background in a Pharmaceutical Production environment (e.g. Production, Product Introduction, Engineering, Quality Assurance)
- Knowledge of typical pharmaceutical production processes, equipment and systems which are used for these processes, and the environment in which these processes run
- Knowledge of the concepts, legislation, guidelines and requirements related to qualification and validation of products, processes, equipment and systems, including Computer System Validation and Part11
- Knowledge of GMP requirements and pharmaceutical legislation - compliance-driven
- Capable of leading cross-functional teams and motivating people
- Good communication and collaboration skills