Manager 1

Job Description

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager 1 Date: Jun 2, 2025 Location: Guwahati - Regulatory Affairs Company: Sun Pharma Laboratories Ltd Sr. No. Responsibilities To facilitate harmonize and consistent implementation of Quality System and procedures at site alignment with Corporate Quality Policies/Procedures. To review documents pertaining to QMS & Compliance. Responsible for ensuring compliance of Quality Management System. To attend Site Training Program as per site training program and Global Quality Standards requirements. Dossier documents Submission after review against request received from Corporate regulatory affairs. Query response for submitted dossier against request received from Corporate regulatory affairs. Export dispatch related query response for approved art work of printed PM, Primary-packing material, overprinting and if other requirement is there. Export Harmonization activity between existing and new change implement for Product. Review and approval of change control and deviation through QMS software and prior approval activity from Regulatory if require as an impact analysis with require detail. Initiation of extension and variation proposal through QMS software Regulatory impact handling for Pharmacopoeia change like IP,BP,USP implementation for export market products. Location RA - Approval to Process Validation summary. Other departmental documents where signature require as location regulatory approval like APR, etc. Product approval package review, approve and share approval detail to respective department. Any Additional activity allocated by the department head and site head. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less