Executive, IPQA

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 350,000 - 500,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad, India, is seeking an IPQA professional to ensure cGMP compliance on the manufacturing and packaging floors. You will perform real-time monitoring, documentation review, sampling, and area/machine clearances to support high-quality injectable products.

The role requires strong written and spoken English, a B.Pharm degree, and 1 year or more in 2-4 years of IPQA exposure. Preferred candidates may hold an MS/ MS Pharm qualification.

Qualifications

• Bachelor’s degree in Pharmacy is required.
• GMP experience and in-process quality assurance understanding.
• 1 year or more in 2-4 years of IPQA roles preferred.
• Strong documentation and record-keeping skills.

Responsibilities

• Perform in-process QA activities on manufacturing and packaging floors.
• Review and ensure cGMP compliance and documentation.
• Conduct sampling and area/machine clearances as per BPR and protocols.
• Issue labels, medication guides, and ensure traceability on batches.
• Maintain audit-ready IPQA records and support investigations.

Skills

cGMP compliance

In-process QA

Documentation review

Real-time monitoring

Batch records

Communication (English)

Education

B.Pharm

M.S./M.Pharm (preferred)

M.S./M.A. (preferred)

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.

Education

• Bachelors Degree (BA/BS) B. Pharm - Required
• Master Degree (MS/MA) M. Sc. - Preferred
• Master Degree (MS/MA) M. Pharm - Preferred

Experience

• 1 year or more in 2 - 4 Years