Description
Main Responsibilities:- Prepare, review and execute site validation protocols (e.g. equipment, utilities, processes, cleaning, test methods and software).
- Support computer systems validation elements of the transfer project.
- Plan validation project schedules and prioritize validation activities in line with schedules and overall technology transfer priorities.
- Support and implement validation projects and activities in conjunction with multifunctional project teams.
- Provide validation related support to all departments.
- Provide technical input during investigations, gap analysis, risk assessment and change control process.
- Support internal and external audits.
- Support DBS process / project management systems.
- Co-ordinate/supervise contractor activities as required.
Education/ Experience
- Bachelor's Degree in a relevant Science or Engineering discipline is required
- Minimum of 2-3 years relevant validation experience in either Medical device or Pharmaceutical Industry (FDA/IMB regulated)