Title:  Manager IPQA

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