Job Description

Job Responsibilities:

Responsible for maintaining cGMP and Good laboratory practices. Responsible for maintaining General cleanliness of laboratory. Responsible for monitoring of exhibit batch analysis with quality control person. Responsible for preparation of instrument methods, methods sets and review of sample sets processing methods, generated in Empower software. Responsible for Analytical method transfer, method verification and method validation. Involve in Raw material, Finished product and Packaging material analysis. Responsible for preparation and review of protocols for method transfer, method verification and method validation. Responsible for preparation and review of reports for method transfer, method verification and method validation. Review and maintain of reconciliation of electronic data generated in quality control laboratory during analytical method validation, verification, technology transfer, development, feasibility study. Responsible for review of any laboratory incident occurred during method transfer, method verification and method validation activity and prepare the laboratory incident report for the same. Responsible for archival and retrieval of Analytical development documents from QA department. Responsible for overall compliance of Analytical Documents. Records generated in quality control laboratory. Responsible for providing relevant documents for regulatory filings. Responsible to take part in internal & external audit. Responsible for procurement of columns, chemicals, reference standards, impurity standards for analytical method transfer, method verification and method validation activity. Responsible for initiation of change controls, Deviations/Incidents. Responsible for review of specification and STP. Responsible for timely response to regulatory queries.

Qualification- M. Sc, M. Pharmacy, B Pharmacy