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  in process, finished product and stability analysis as per approved specifications, SOPs, and pharmacopeial methods (USP, EP,JP, etc.).
• To operate the instrument like HPLC, GC, UV, IR , dissolution and karl fischer .
• 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.
• Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor
• Performing qualification, periodic calibration, and maintenance of laboratory instruments.
• Maintain proper cleanliness, calibration, and qualification status of analytical instruments.

• Ensure proper labeling, storage, and disposal of samples and reference standards.

   

Qualifications