SHARAD RAJPUT

• Review the verification and monitoring of the laboratory and its compliance.
• Maintain daily routine GLP activity (e.g., daily verification of balance, temperature monitoring activity, reference and working standard, column management, reagent/chemical management, calibration activity of instruments as per schedule, instrument AMC, indent of laboratory uses, and instrument/equipment logbook verification.)
• Responsible for AMV/AMT-related queries and responses to RA/Customer accordingly.
• Review the analytical method validation protocol and report.
• Audit trail review and software-related activities.
• Review analyst qualifications, instrument qualifications, and calibration.
• Review and ensure that the calibration and qualification of all quality control instruments are done as per the pre-determined schedule.
• Monitor Primary Standard, Reference Standard, Impurities, HPLC columns, and chemicals/reagents.
• Monitoring of preventive maintenance of all instruments/equipment.
• Review of outside party calibration, qualification, with certificate.
• Aware of regulatory requirements.
• Monitor Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in the laboratory.

• Review the verification and monitoring of the laboratory and its compliance.
• Review of all laboratory OOS, OOT, change control, deviation, and laboratory incident.
• Verification of good laboratory practices, and good documentation practices, in the laboratory.
• Review STS and STP of raw material, packing material, in-process, and finished products, stability data.
• Verification of all electronic data and audit trails of all instruments in the quality control laboratory.
• Review the analytical method validation protocol and report.
• Audit trail review and software-related activities.
• Review analyst qualifications, instrument qualifications, and calibration.
• Review and ensure that the calibration and qualification of all quality control instruments are done as per the pre-determined schedule.
• Monitoring of preventive maintenance of all instruments and equipment.
• Review of outside party calibration, qualification, with certificate.
• Review Micro related activities
• Aware of regulatory requirements.
• Monitor Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in the laboratory.
• To review the calibration data, working standard qualification data, and analytical reports of finished products, semi-finished products, stability samples, and other samples tested in the Quality Control department.
• Monitor the stock of spare parts for instruments as per requirements.
• Monitor Primary Standard, Reference Standard, Impurities, HPLC columns, and chemicals/reagents.
• Responsible for the review of analytical technology transfer data, report, protocol, and coordination with cross-functional departments for the execution of activities.

To ensure compliance with Quality Control SOPs.

Review all the documents and ensure cGLP practices in the quality control laboratory.

To ensure 21 CFR Part 11 compliance in the quality control laboratory.

Responsible for the review and approval of OOS investigations, OOT investigations, deviations, laboratory incidents, CAPA, and change control.

To ensure proper documentation and submission of the report by QC.

Responsible for the review of documents of the calibration planner, certificate, calibration data, and preventive maintenance planner and schedule.

Responsible for planning the review specification, test data sheet, finished product, and in-process stability product.

Responsible for the preparation and review of analytical method validation/verification protocols and reports.

Responsible for the review of analytical technology transfer data, reports, protocols, and coordination with cross-functional departments for the execution of activities.

Responsible for reviewing the audit trail of the QC department.

• Handling the GLP, RM, Finish, and Stability sections independently with a team size of 20 to 25.
• Quality Control Audit Compliance.
• Initiation and execution of deviation, incidents, and OOS in the QC department.
• Responsible for the compliance of the Good Laboratory Practices on a day-to-day basis.
• General cleanliness and orderliness in the laboratory.
• Management of reference standards and working standards.
• Training and development of QC analysts.
• To ensure that all applicable SOPs are up to date, understood, and followed by each individual, and that everybody is trained in SOPs.
• To ensure the calibration of QC instruments as per the calibration schedule.
• Review of calibration data.
• To ensure all documents are properly filled out after the completion of the activity.