Executive, IPQA

6 days ago


India Amneal Full time ₹ 6,00,000 - ₹ 12,00,000 per year
Description

Description:

To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitoring, documentation review, sampling, and area/machine clearances, thereby supporting the production of high-quality injectable pharmaceutical products

Essential Functions:

  • To ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
  • To supervision of dispensing activity of manufacturing shop floor and packing areas.
  • Responsible for providing machine and area clearance.
  • To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol.
  • Online Documents and records review like equipment's logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
  • Calibration of IPQA instruments.
  • Review of and release of Batch.
  • Responsible to review the in-process and finished product COA before batch release.
  • To perform aseptic behaviour/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.

Additional Responsibilities:

  • Real-time Monitoring and Compliance Reporting.
  • Participation in Investigations.
  • Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.
  • Maintain IPQA-related documents and records in a state of audit readiness.
  • To have good written and verbal communication skills in English language.

Skills:

  • In-Process Quality Control (IPQC) - Mastery
  • Compliance and Regulatory Knowledge - Advanced
  • Aseptic Process Monitoring & Compliance - Advanced
  • Line Clearance & Batch Record Review - Intermediate
  • Deviation, Investigation & CAPA Management - Advanced
  • In-Process Checks & Monitoring - Mastery
  • Deviation & Change Control Management - Advanced
  • Equipment & Facility knowledge - Advanced
  • Investigation Skills for Root Cause Analysis - Advanced
  • Analytical Quality Assurance - Advanced
Qualifications

Education: B.Pharm / M.Sc / M.Pharm
Experience: Years



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