- Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM).
- Initiate, change controls, incidents, and risk assessments related to technology transfer activities.
- Support technology transfer activities for recent products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
- Coordinate with cross-functional teams for execution and documentation of new products, scale-ups, and line or site transfers.
- Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
- Preparation and review of Cleaning Validation and process related documents (Protocols, Reports, Master Plan and Assessments etc.)
- Preparation and review of CPV schedule and reports.
- Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
- Collaborate with cross-functional teams to improve manufacturing processes




- Conduct data analysis to identify trends and opportunities for process improvement
- Assist in the implementation of process improvements and new technologies
- Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements Include in the identification of the Root cause analysis for any OOT / OOS of the Products introduced at sterile facilities till Process validation.
- Support for Regulatory filings and Compliance issues for Sterile injectable products.
- Support for Regulatory audits.
- Absorb and transfer the products from the transferring site to FTO-11 and other sterile facilities with Pro-active approaches and risk mitigation strategies.

Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy

Skills: Data Analysis, Cleaning Validation, Technology Transfer, Process Validation

Experience: 0.00-0.00 Years

📌 MSAT Specialist (India)
🏢 Monster - xshruthix
📍 India