Sr. Officer, Quality Control

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.