Job Role: Analytical Validation
Department: Analytical Development
- 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 specifications and STP’S.
- Responsible for timely response to regulatory queries.
- Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HODs instruction and guidance.
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