Executive

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.