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 new 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.