Job Description

• Follow the standard operating procedure (SOP) relevant to the analysis of the products.
• Review of verification & method validation protocols for analytical methods inclusive of Assay, related substances and residual solvent.
• Responsible to resolve any regulatory queries related to analytical methods and related impurities.
• To receive the documents viz, Specification, SOP, Formats and test protocols etc. as required for the system.
• Manage the compliance to each deficiency found in the quality control system.
• Establishing specification and method of analysis of RM, PM, & FP.
• Ensure completeness of documentation and validation of process & analytical methods as per cGMP requirements.
• To maintain discipline at QC department.
• Involved in the Analytical Method development and Validation Activities.
• Resources and Man Power Management.
• Authority to approve or disapprove any material viz., RM/PM/INT/FP or any incoming material subjected to quality matters, on consultation with Head Quality if require.
• Report directly to the Head Quality on quality related matter.
• In absence, Executive - QC or Officer - QC shall look after the work.
• Review of In-process testing report, Raw material Testing Report, Packing material testing report and FP testing report.
• Review of Calibration analytical instruments as per calibration planner. Record.
• Monitoring of Laboratory chemicals.
• Purchase requisition slip in SAP system Approved.
• RM/PM/FP result Review and approve in SAP system.
• New MIC Create in SAP System (new product create MIC in SAP system & any Pharmacopeia change create MIC).
• Lab Chemical Received and Lab Chemical issue entry in SAP system.
• Service PR approve in SAP system.
• Revise SOP as and when required. Prepare new SOP as per requirement.

Ciel HR