- Prepare and review SOPs related to validation and qualification activities.
- Execute and compile Media Fill (Aseptic Process Simulation) protocols and reports.
- Perform Process Validation, Cleaning Validation, Cleaning Verification, and Hold Time Studies.
- Execute qualification and requalification activities for Manual Visual Inspection processes.
- Conduct risk assessments for equipment and manufacturing processes.
- Ensure compliance with cGMP requirements and validation guidelines.
- Coordinate with cross-functional teams for validation activities and documentation.
Preferred candidate profile
- Experience in pharmaceutical validation and qualification activities.
- Hands-on exposure to Media Fill, Process Validation, and Cleaning Validation.
- Knowledge of risk assessment methodologies and cGMP requirements.
- Robust documentation and report-writing skills.
- Good communication and stakeholder management skills.