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

Start Date

Immediate

Expiry Date

24 Jun, 26

Salary

0.0

Posted On

26 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Cgmp, Regulatory Requirements, In-process Quality Assurance, Real-time Monitoring, Documentation Review, Sampling, Area Clearances, Machine Clearances, Dispensing Supervision, Label Issuance, Batch Packaging Record Review, Stability Study Protocol, Logbook Review, Calibration, Investigation Participation, On-the-job Training

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 Officer, IPQA ensures compliance with cGMP and regulatory requirements by conducting in-process quality assurance on the shop floor, including real-time monitoring, documentation review, sampling, and issuing clearances for manufacturing and packaging operations. Key duties involve supervising dispensing, issuing labels, reviewing various operational records, and performing instrument calibration to support high-quality injectable pharmaceutical production.