Job Title: Manager II - Health Authority Communications
Date: Dec 25, 2024
Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd
Position: Manager II – Health Authority Communications
Reports To: Head of Health Authority Communication and Correspondence
Department: Global Quality
Functional Area: Global Quality
Location: Mumbai
The Manager II – Health Authority Communications will play a key role in supporting global health authority communications and ensuring regulatory compliance throughout the organization. This position works closely with the Head of Health Authority Communication and Correspondence to coordinate regulatory responses, manage quality deliverables, and prepare materials for regulatory meetings.
The role involves ensuring compliance with all regulatory requirements, Good Manufacturing Practices (GxP), and other applicable department programs. The Manager II will assist in identifying and resolving compliance risks and support the remediation process.
This position is ideal for a Quality professional with experience in manufacturing environments (e.g., aseptic, solid oral dose) and Quality Management Systems, aiming to contribute to health authority communications.
Health Authority Correspondence Management:
Assist in reviewing and preparing scientifically accurate, compliant responses to health authority queries and inspection observations. Collaborate with site teams to gather data and draft responses. Track and document all regulatory communication activities in regulatory databases in a timely manner.
Quality Management System Analysis:
Analyze inspection, audit, and QMS findings to identify areas for global risk mitigation. Support internal teams in developing corrective actions.
Inspection Readiness:
Provide support for regulatory audits, internal/external inspections, and mock inspections. Review documents to ensure compliance with current regulations.
Compliance Tracking and Reporting:
Monitor regulatory updates, perform gap assessments on regulatory requirements (especially in aseptic environments), and ensure compliance with quality management.
Additional Assignments:
Perform other tasks as needed.
This job description reflects the general nature and level of work being performed. Other duties and responsibilities may be assigned as needed.
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