This role is responsible for establishing and ensuring adherence to standardized validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.
- Responsible for supporting the activities of operations, engineering, and information management in building product quality into products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.
- Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.
- Run and manage complaint investigation and resolution of same.
- Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements.
- Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation.
- Bachelor's degree in a relevant discipline.
- 3 years' experience in a Quality function within the Medical Device/ Pharmaceutical industry.
- Validation experience is a must.
- Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.
- Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
- Have a proven track record in development/execution of Validation programs in areas of Equipment, and Process Information management.