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 Positive 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.

📌 Sr. Officer, Quality Control (Secunderabad)
🏢 Amneal Pharmaceuticals
📍 Secunderabad