Interested candidate can share their CV on [email protected]

Role & responsibilities for IPQA:

- Assist in defining and specifying quality activities, processes, and standards for in-process quality assurance in pharmaceutical manufacturing in accordance with cGMP requirements
- Participate in auditing and monitoring in-process manufacturing activities and outputs against defined internal and regulatory standards
- Assist in maintaining efficient workflows, procedures, policies, and inspection programs within the IPQA function
- Support in-process quality monitoring activities and assist in managing quality-related interactions with vendors
- Contribute to reporting and troubleshooting manufacturing process deviations and defects in finished goods
- Assist in compiling APQR reports and maintaining quality documentation in compliance with 21 CFR Part 210 and 211
- Support change control and deviation management processes under the guidance of senior quality personnel
- Participate in complaint and recall assessment activities and contribute to corrective and preventive action implementation

Role & responsibilities for IPQA EM:





- 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.
- Responsible 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 equipments 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 valuable written and verbal communication skills in English language.

📌 Officer / Executive _ IPQA / IPQA EM (Gujarat)
🏢 Amneal Pharmaceuticals
📍 Gujarat