Short statement stating exact purpose of the role:
Support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations,
Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions,
Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements,
Implement Client policies and procedures.
Responsibilities:
Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our 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
Runs /Manages complaint investigation and resolution of same
Designs and develops validation documentation to support business continuity, new process introductions
Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Essential:
A Bachelor's degree from accredited college
3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.
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, Process Information management
Ability to demonstrate standards of leadership - Managing Complexity/Credo Values/Innovations/Customer focus.
Flexible
Team Player
Good Influencing Skills
Project Management Skills
Good generalist
Good communication skills
Methodological
Desirable:
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.