Senior Officer, QC Stability

Amneal Pharmaceuticals

2 - 7 years

4 - 5 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

product quality finished products pharma regulatory compliance glp data integrity analytical instruments hplc preventive maintenance testing

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled and experienced Senior Officer, QC Stability to join our team at Amneal Pharmaceuticals. The ideal candidate will have 2-7 years of experience in stability testing of injectable pharmaceutical products.

Roles and Responsibility

Conduct stability testing of injectable pharmaceutical products to ensure compliance with regulatory standards and product quality throughout the shelf life.
Perform analysis of stability samples as per approved stability protocols using analytical techniques such as HPLC, GC, UV, etc.
Maintain cleanliness and follow GLP in the laboratory, including real-time documentation in LIMS/LNBs and upkeep of instrument logbooks.
Initiate and assist in the investigation of laboratory events including deviations, out-of-specification (OOS), and out-of-trend (OOT) results.
Prepare and review Certificates of Analysis (COAs), stability summary reports, ensuring data integrity and compliance with cGMP and regulatory standards.
Test miscellaneous materials, in-process, finished products, and stability samples according to the stability protocol.

Job Requirements

Expertise in HPLC, GC, UV, and stability testing protocols is required.
Knowledge of GLP, cGMP, LIMS/LNB, and data integrity is essential.
Experience in COA preparation, report review, and regulatory compliance is necessary.
Ability to handle OOS/OOT/deviations and documentation effectively.
Testing of raw materials, in-process, finished products, and stability samples is expected.
Participation in and conduct of training sessions for new team members and peers is desired.

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