Quality Assurance Manager

Lupin

Fresher

Pune, India

Posted 3 hours ago
Be among the first 10 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:

Industry:

Function:

Employment Type:

About Company

Lupin

Job ID: 153648193

Jobs by Skill - IT

Jobs by Skill - Non IT

International Jobs

Last Updated: 01-09-2026 09:23:14 PM

Homejobs in PuneQuality Assurance Manager

Similar Jobs

Quality Assurance Manager

Lupin

Pune, India

Skills:

Cleaning Validation, Quality Technical Agreements, Process Validation, GMP Compliance, Annual Product Quality Review, Batch Processing Records, Qualification, Analytical Records, Media Fill Validation, Cgmp, Corrective and Preventive Actions, Ipqa