Title: Manager - 2

Date: May 3, 2024



Location: Dewas SGO - Plant



Company: Sun Pharmaceutical Industries Ltd







Responsibilities:

• Responsible for regulatory compliance function at Dewas location.
• Review/Approval of operational documents including Formulation Order Manufacturing Instruction, Packaging Order Packaging Instruction, Process Performance Qualification Protocols/Reports, Stability Protocol, Stability termination notes, Artworks, Active pharmaceutical ingredient specifications, Finished Product Specifications, Packaging Material specifications, Raw Material specifications, Annual Product Review, Market diversion, Material code transfer, Repackaging Request, Equipment Equivalence certificates, Protocols, Out specification/Trend investigation Protocol/Reports, Exhibit batch destruction Reports and Conditional release.
• Arranging Registration Samples/Placebo/Working standard for filing.
• Applying for Copp, DML, FSC applications
• Verification of regulatory compliance/commitments of vendor.
• Review of RFC with respect to confirmation on regulatory compliance and supply continuation.
• Review/circulation of Approval Package/License Particular with respect to operational documents and circulation of Approval Package/License Particular /Quarantine tracker in plant.
• Alert mail coordination/circulation and Recipe Locking/Unlocking activity.
• Review and approvals of change controls and deviations.
• Support to filings, deficiencies, variations and Annual updates.
• To ensure regulatory compliance with respect to filing and approval.
• Tracking of regulatory approvals and implementations.
• Coordination for fulfillment of regulatory commitments.
• Participation in Quality review Board meetings at manufacturing locations.
• Ensure compliance with Regulatory affair SOPs.
• To ensure Business Continuity by providing inputs and strategies to ensure timely renewals and variations.
• To ensure Business Continuity by providing feedback for resolving issues and changes related to manufacturing process, equipment, material, quality, lab etc., through appropriate regulatory decisions and wherever needed coordinating for filings/approvals.
• To ensure Business Continuity by coordinating with country specific regulatory agencies to bring clarity on how to handle new issues in a productive manner and to provide differentiated solutions to problems.

Delegation of Responsibility : In the absence of job holder, delegation of responsibility shall be proceed as follows: Upward Delegation : - Strategic site responsibilities upward to higher level. Downward Delegation : - Operational responsibilities downward to direct reporters or similar Job role.