Posted 3w ago

Executive, IPQA

@ Amneal Pharmaceuticals
Ahmedabad, Gujarat, India
OnsiteFull Time
Responsibilities:monitoring quality, reviewing documents, calibrating instruments
Requirements Summary:B. Pharm required; 2-4 years experience in IPQA/QA in pharma manufacturing.
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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.
  • To Issuance of Bottle label, Ouster and Medication guide for commercial batch.
  • Rsponsible 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.


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.

Qualifications

Education:

  • Bachelors Degree (BA/BS) B. Pharm - Required

Experience:

  •  2 - 4 Years