Manager Quality Assurance | Sun Pharma | Halol

Job Description

Manager Quality Assurance (IPQA)

Job 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 officers and contact 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

Educational Qualification – B.Pharma, M.Pharma

Experience – 14 to 16 Yrs

Location – Halol