Title: Manager IPQA

Location: Halol 2 – Quality Assurance

Company: Sun Pharmaceutical Industries Ltd

Position: Manager – IPQA

Job Grade – Manager

Qualification: B.Pharma/M.Pharma.

Experience: Minimum 15+ years with (USFDA OSD Experience)

KEY RESPONSIBILITIES:

- This position leads Inprocess Quality Assurance (IPQA) for Non-Sterile manufacturing block to ensure that all operational activities of Quality Assurance are followed to ensure the supply of high-quality, GMP-compliant drug products from the site.
- Assure all-time readiness of site for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams
- Proactively assess quality issues at the site and ensure compliance to regulatory requirements in manufacturing operations at the site and track quality metrics with site manufacturing and drive them down
- Prioritizing and monitoring the activities of QA officers for accuracy and compliance
- Planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or procedures.
- Appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams. Sustain substantial compliance with quality operations at the site
- Responsible for identifying and investigating Data Integrity Observations and taking appropriate CAPA to avoid repeat observations
- Responsible for ensuring market complaints, failures, and deviations are investigated and corrective and preventive actions are implemented as per set timelines.
- Execution of training for QA officer and contract persons.
- Release of Bulk product for further stage.
- Release of product for commercial dispatch
- Monitor the quality policies, standards, and procedures for computerized systems that are implemented/established and adhered to at the site.
- Monitor the QMS (Deviations, Change Control, CAPA, etc.) are closed in a timely manner