- Providing site QA oversight and approval of validation lifecycle documentation for plant equipment, IT / automation systems, facility and utility systems
- Coordination of site periodic review program
- QA oversight on data integrity for IT and automation systems
- Providing QA oversight and approval for change controls, deviations and CAPAs
- Management and implementation of validation masterplans and SOPs
- Degree level qualification in Science/Engineering or equivalent
- Minimum 8 years' experience in a Quality role within Pharmaceutical/Medical Device industry.
- Proven ability to successfully introduce new product development in the Medical Device/Pharmaceutical Industry.
- Proven knowledge and ability regarding product verification and process validations including software and automation experience.
- Proven knowledge of FDA and MDD GMP requirements regarding Medical Devices and Pharmaceutical.