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Executive, IPQA at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Cgmp, Regulatory Compliance, Quality Assurance, In-process Quality Assurance, Documentation Review, Sampling, Machine Clearance, Dispensing Supervision, Batch Packaging Record, Calibration, Environmental Monitoring, Audit Readiness, Communication Skills, Training, Investigation

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
The Executive, IPQA is responsible for ensuring cGMP compliance on the manufacturing and packaging shop floor through real-time monitoring, documentation review, and area clearances. They also conduct sampling, supervise dispensing activities, and maintain records in a state of audit readiness.