Description
Validation Engineer: Medical Devices, Pharmaceuticals, GxP, FDA
1.Job Purpose:
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 J&J policies and procedures.
2.Responsibilities:
Main areas of responsibility:
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.
3.Education and Experience Required for Role
Essential:
Bachelors 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
Methological
Desirable:
Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.