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Amneal Pharmaceuticals
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Sr. Officer, Quality Control

Sr. Officer, Quality Control

Amneal Pharmaceuticals

3 - 7 years

5 - 9 Lacs

Hyderabad

Posted:23 hours ago| Platform:

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Skills Required

QA Usage Method validation Analytical Packaging GLP Analytical instruments Continuous improvement Manufacturing operations Regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Description:

To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products.

Essential Functions:

Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc.).
Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP).
Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage.
Performing qualification, periodic calibration, and maintenance of laboratory instruments.
Maintain proper cleanliness, calibration, and qualification status of analytical instruments.
Coordinate with warehouse and QA for sampling of incoming materials as per SOPs.
Ensure proper labeling, storage, and disposal of samples and reference standards.
Support internal, customer, and regulatory audits by providing required documentation and clarifications.
Implement corrective and preventive actions (CAPA) as per audit observations.

Additional Responsibilities:

Participate in method validation, verification, and transfer activities as required.
Assist in updating and reviewing SOPs, specifications, and analytical procedures.
Contribute to continuous improvement initiatives in the QC department.
Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor.
Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

5001-10000 Employees

439 Jobs

Key People

Chirag and Ameet N. Patel

Co-CEOs
Kamran Alam

CFO
D. J. Barlow

Chief Commercial Officer
Robert O'Neill

Chief Operating Officer

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Sr. Officer, Quality Control