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Assistant Manager, Quality Assurance at Amneal India
, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

0.0

Posted On

14 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

cGMP Compliance, Regulatory Requirements, In-Process Quality Assurance, Documentation Review, Sampling, Area Clearance, Machine Clearance, Supervision, Batch Review, COA Review, Aseptic Monitoring, Compliance Reporting, Investigations, On-the-Job Training, Record Maintenance, Written 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. 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 equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc.. Calibration of IPQA instruments. Review of and release of Batch. Responsible to review the in-process and finished product COA before batch release. To perform aseptic behaviour/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP. 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 primary role involves ensuring compliance with cGMP and regulatory requirements by conducting in-process quality assurance activities, including real-time monitoring, documentation review, and sampling on the manufacturing and packaging shop floor. This position is also responsible for supervising dispensing activities, providing area/machine clearances, and reviewing batches and Certificates of Analysis (COA) before final release.