Senior Executive, IPQA EM

Amneal India; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal India is seeking an IPQA professional to ensure cGMP compliance on the manufacturing and packaging shop floor. The role involves real-time monitoring, documentation review, and sample testing to support high-quality injectable products.

You will supervise dispensing activities, issue batch-related labels and guides, and maintain calibration and audit-ready records. Strong written and verbal English communication is required, with training provided to shop floor personnel.

Qualifications

• Bachelor's degree in Pharmacy or related field.
• IPQA experience in pharma manufacturing is preferred.
• Knowledge of regulatory compliance and documentation practices.

Responsibilities

• Perform in-process quality assurance on manufacturing and packaging shop floor.
• Review real-time documentation and monitoring records for compliance.
• Issue labels, o스터 and medication guides for commercial batches.
• Calibrate and maintain IPQA instruments and calibrations.
• Conduct sampling (reserve, stability, in-process) per BPR and protocols.
• Maintain audit-ready IPQA records and support investigations.
• Provide on-the-job training on GMP practices and documentation to shop floor staff.

Skills

cGMP awareness

IPQA experience

Quality documentation

English communication

Education

Bachelor's degree in Pharmacy or related field

Job 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.