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 \xe2\x80\x93 QC or Officer \xe2\x80\x93 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.