1.1 Ensure availability of Resources and Training to QC personnel.
1.2 To develop systems and procedures (SOPs) for conducting QC functions as per the requirements.
1.3 To ensure the adherence to systems and procedures by all the QC personnel.
1.4 To ensure that the Analytical data is accurate and adequate for the purpose.
1.5 To organize the analysis and approval/ rejection of various raw materials / packaging materials and release of finished product for manufacture / packing.
1.6 To conduct the QC operation in strict adherence to cGMP and cGLP.
1.7 To participate and organize Analytical method transfers, equipment validation, process validations, cleaning validations, vendor qualification of materials & change control mechanism.
1.8 To ensure that all the equipment and instruments are in validated and calibrated state.
1.9 To organize proper maintenance of reference standards, primary standards & working standard of drug product inputs.
1.10 To investigate deviations, Incidents, OOT and OOS results and to take remedial measures.
1.11 To prepare and track the trends in Analysis of various drug product inputs and drug products
1.12 Approval of STPs / Specifications / SOP / Analytical test report.
1.13 To organize and ensure analysis of stability samples / market complaint samples.
1.14 To organize contract laboratory audits and certification.
1.15 To participate in change control process as and when required.
Ready to relocate ,
Knowledge of control process,
Analysis of market complaint samples/ stability samples