Role & responsibilities

- 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.

- Solid documentation and report-writing skills.

- Good communication and stakeholder management skills.

📌 Executive - QA Validation (Mumbai)
🏢 Bharat Serums and Vaccines
📍 Mumbai