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

Start Date

Immediate

Expiry Date

23 Jun, 26

Salary

0.0

Posted On

25 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

cGMP Compliance, Regulatory Requirements, In-Process Quality Assurance, Real-time Monitoring, Documentation Review, Sampling, Area Clearance, Machine Clearance, Dispensing Supervision, Label Issuance, Batch Packaging Record Review, Environmental Monitoring, Calibration, Investigation Participation, On-the-Job Training, 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. * 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 role ensures compliance with cGMP and regulatory requirements by executing in-process quality assurance on the manufacturing and packaging shop floor, including monitoring, documentation review, sampling, and issuing clearances. Essential functions involve supervising dispensing, issuing labels, reviewing various operational records, and performing instrument calibration.