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Officer, IPQA at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

10 Sep, 26

Salary

0.0

Posted On

12 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Compliance, In-Process Quality Assurance, Documentation Review, Sampling, Area Clearance, Machine Clearance, Batch Packaging Record, Calibration, Environmental Monitoring, Quality Standards, Technical Writing, Verbal Communication

Industry

Pharmaceutical Manufacturing

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.

Responsibilities

Ensure compliance with cGMP and regulatory requirements through real-time monitoring and quality assurance activities on the manufacturing and packaging shop floor. Responsibilities include performing area clearances, sampling, and reviewing online documents and records for injectable pharmaceutical products.