- Design, develop, test, and validate manufacturing processes using GAMP principles to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify areas for improvement in production operations and implement changes to increase efficiency and quality.
- Develop and maintain documentation of validation protocols, reports, and records according to cGMP guidelines.
- Troubleshoot issues related to equipment calibration, cleaning validation, sterilization validation, and process deviations.
Job Requirements :
- 7-20 years of experience in pharmaceutical or life sciences industry with expertise in GXP (Positive X Practices) regulations.
- Strong understanding of HP ALM (Manufacturing Execution System) software application.
- Experience with MES (Manufacturing Execution System) implementation projects.