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H
Hcfa

Executive, IPQA

India
Full-time
Posted 2d ago
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Job 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

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

Experience:  2 - 4 Years

Benefits & Perks

vision of dispensing activity of manufacturing shop floor and packing areas.

Frequently Asked Questions

How to apply for Executive, IPQA at Hcfa?

Click the "Apply on Company Website" button on this page to submit your application directly on the employer's official portal.

What is the salary for this role?

Salary details will be discussed during the interview.

What experience is required?

This position is open to freshers and experienced candidates.

Is this position still open?

Yes, currently active and accepting applications.

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Hcfa

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Executive, IPQA

Hcfa · India

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