Samir Kumar Patel

Validation section:

· Preparation, review, execution, compilation and approval of Process validation activity in accordance with the CPP and CQA as per the current and traditional approach.

· Preparation, review, execution, compilation and approval of Cleaning validation in accordance with the worst case concept through manually or software (e residue).

· Preparation, review, execution, compilation and approval of Hold time study .

· To execute and do the qualification quipment/facility qualification activity (IQ,OQ,PQ protocols of all equipments, AHU, area, and facility of oral (tablet ,capsule and injectable / Parenteral section)in accordance with current regulatory requirement.

· Updation of VMP status as per the frequency online besis.

QMS section:

· Handling of quality management system(QMS).

· Updation and monitoring of quality matrix on daily and weakly basis.

· Analysis and preparation of quality risk assessment.

· Monitoring and closing of event/deviation/PNC reports, by review the investigation reports with effective CAPA implementation.

· handling of change controls, planned modifications with proper implementation and closing.

· Handling of market complaints, with effective CAPA and closing

· Implementation of corrective and preventive actions as recommended in the quality documents.

· Preparation and review of QRM.

· Carrying out internal quality audits in adherence to cGMP norms and preparation of report.

· Preparation of quarterly, half-yearly and yearly QMS (change control, deviation, oos ) trending and summary data.

Documentation:

· Trained Key User of ERP/SAP system involving Updation of bill of materials, formula, recipe and routing etc.

· Review of master batch manufacturing records of commercial/exhibit batches as well as prior to RA submission.

· Preparation and reviewing of master batch manufacturing & packing records prior to their approval.

· Assigning of any other responsibility given by officially reporting head or department head.

Subfloor activity(IPQA):

· Review of Executed batch manufacturing records of commercial/exhibit batches as well as prior to RA submission.

· Line clearance activity in overall oral solid and injectable manufacturing and packing section.

· Batch release after packing.

· Daily verification GMP records related to manufacturing and packing.