Officer, IPQA

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 450,000 - 650,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an IPQA professional to ensure cGMP compliance on the manufacturing and packaging shop floor, including real-time monitoring, sampling, and documentation review.

The role involves dispensing activity supervision, issuing bottle labels and related documents, maintaining readiness for audits, and providing GMP training to shop floor personnel. Strong written and verbal English communication is required.

Qualifications

• Knowledge of cGMP and regulatory requirements on manufacturing floors.
• Ability to review documentation and ensure audit readiness.
• Experience with sampling, area and machine clearances, and in-process checks.

Responsibilities

• Real-time monitoring on the shop floor and compliance reporting.
• Investigations participation and documentation of findings.
• Provide on‑the‑job training on GMP practices and documentation.

Skills

cGMP knowledge

QA procedures

Documentation review

In-process checks

Team supervision

Tools

IPQA instruments

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.