Description:
An exciting opportunity for an experienced Validation interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.
Role Responsibilities
- Serve as validation representative for cross functional projects and represent the validation team at global technical forums
- Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
- Supporting regulatory audits and submissions as required.
Prefered Experience
- Equipment Periodic Validation
- Equipment Validation Lifecycle
- Project Management Skills/Qualification
- Filter Validation & Container Closure Validation
- Autoclave/SIP Sterilisation Validation
- Dry Heat Sterilisation
- Isolator Qualification
- Vial and Syringe Processing Technologies
- Temperature Mapping
- Cleaning Validation