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Amneal Pharmaceuticals
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Executive, IPQA

Executive, IPQA

Amneal Pharmaceuticals

3 - 6 years

5 - 8 Lacs

ahmedabad

Posted:21 hours ago| Platform:

Apply

Skills Required

manager quality assurance analytical pharma shop floor inprocess quality packaging manager quality control gmp monitoring auditing

Work Mode

Work from Office

Job Type

Full Time

Job 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 itoring, 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 itoring 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 a tic behaviour/practice itoring of operators (while working inside a tic process area) during each a tic batch (GMP batch) as per SOP.

Additional Responsibilities:

Real-time itoring 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.

Skills:

In-Process Quality Control (IPQC) - Mastery
Compliance and Regulatory Knowledge - Advanced
A tic Process itoring & Compliance - Advanced
Line Clearance & Batch Record Review - Intermediate
Deviation, Investigation & CAPA Management - Advanced
In-Process Checks & itoring - Mastery
Deviation & Change Control Management - Advanced
Equipment & Facility knowledge - Advanced
Investigation Skills for Root Cause Analysis - Advanced
Analytical Quality Assurance - Advanced

Disclaimer: The job location mentioned in this description is based on publicly available information or company headquarters. Candidates are advised to verify the exact job location directly with the employer before applying.

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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Executive, IPQA