Job Description :
Must have skills*
- Experience validating GAMP 5 Category 5 equipment with experience in automation, packaging, labelling, and vision systems.
- Experience developing procedures and Work Instructions in conjunction with software stake holders
- Experience of taking part in Risk Management activities as appropriate
-Can perform computerized system category assessment, Risk assessments, 21CFR Part 11 assessment’s and complete system development and implementation following established system change control practices.
- Good Communication Skills
- MDD experience
- Bachelor’s degree
Key responsibilities*
The primary purpose of this job is to support a customer for providing technical support to all equipment computer software validation engineering activities within the Manufacturing group
This position will provide support on equipment validation, CSV assessment, 21CFR Part11 assessment, and validation activities
This position will also include liaison with offshore team to ensure all goals and targets of the validation processes are achieved on time.