Making sure that all Equipment Qualification and Process Validation is performed and following all Company Policies and Procedures. To assist with Validation of IFS and other software systems.
To produce User Specification Requirements (USRs), Validation Protocols and Validation Reports in accordance to company standards. To report any problems with data/results acquired and help in finding solutions.
Gathering and delivering documentation for validation projects. To make sure that validation is performed to the itinerary, that any problems are reported in a timely fashion and that all documentation follows company templates.
Carrying out validation trials following Installation and Operation Qualification protocols documented and documentation of results. Examining and accepting of the same documentation for other operators.
Achieve Performance Qualification/Process Validation trials and documenting results (including appropriate data analysis).
Ability to work as a team in a productive manner as well as working independently.
- A levels or equivalent in Science
- Experience & knowledge of FDA Part 820 and ISO13485.
- Experience & knowledge of Computer software validation, FDA Part 11 and GAMP5
- Experience of working within a Validation or Manufacturing environment
- Keen eye for detail
- Ability to follow processes
- Curious mind
- Open and friendly
- Flexible to cope with changing priorities
- Degree or similar in Biological Sciences or related
- Knowledge of working with IVDs or Medical Devices
- Understanding of cGMP
- Good data examination & report writing skills