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Quality Assurance Manager

Lupin
Fresher
Pune, India
Early Applicant
  • Posted 17 days ago
  • Be among the first 40 applicants

Job Description

  • GMP Compliance – Drug Product Facility
  • Monitor day-to-day activities and plan allocation of IPQA personnel as per batch schedule. Oversee critical manufacturing activities including dispensing, in-process checks, sampling, filling, sealing, visual inspection, and AQL.
  • Coordinate with Drug Product (DP) teams for smooth batch execution from dispensing to dispatch.
  • Review technical documents related to drug product manufacturing.
  • Media Fill, Validation, and Qualification
  • Review media fill protocols and reports in compliance with current regulatory guidelines. Ensure equipment and area qualifications, including periodic requalification for drug product facilities.
  • Review process validation and cleaning validation protocols and reports.
  • Ensure availability of visual inspection qualification kits.
  • Contract Manufacturing Organizations (CMOs) Activities
  • Ensure manufacturing and analytical activities at CMOs are conducted in compliance with Quality Technical Agreements and cGMP requirements.
  • Coordinate and communicate with CMO manufacturing and analytical teams for timely execution and tracking of activities.
  • Identify the need for new procedures and ensure their implementation; perform gap analysis of existing procedures.
  • Review executed Batch Processing Records (BPR) and Analytical Records (AR) for batch release, and coordinate with CMOs to ensure compliance.
  • Review and approve Annual Product Quality Review (APQR) reports for products manufactured at CMOs.
  • Market Complaint and Recall Activities
  • Manage market complaints including registration, communication with complainants and DSRM, investigation, and implementation of corrective and preventive actions (CAPA).
  • Notify stakeholders regarding product or batch recalls/market withdrawals

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceutical
Employment Type:
Full time

About Company

Job ID: 152357893

Last Updated: 25-08-2026 02:58:35 PM
Homejobs in PuneQuality Assurance Manager

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Quality Assurance Manager

Lupin
Pune, India

Skills:

Cleaning Validation, Quality Technical Agreements, Process Validation, GMP Compliance, Annual Product Quality Review, Batch Processing Records, cGMP requirements, Qualification, Analytical Records, Media Fill Validation

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