Deputy manager-Exhibit QC
Granules india ltd
04.2023 - Current
- Review and approval of analytical method validation protocols and Validation reports
- Review and approval of protocols and reports related to Analytical method verification of compendial methods and site transfer products
- Review of analytical method validation raw data and reports and ensure the methods to in line with validated reports
- Responsible for QMS tools (Incidents, OOS, OOT, Deviations, Change controls and CAPA’s) initiation, involvement of investigations and closures
- Review of electronic data and audit trail reports generated from computerized system as part of 21cfr part 11 compliance
- Good Laboratory practices
- Good Documentation practices
- Responsible for standard operating procedures preparation/review/approvals as per requirement
- Responsible to ensure data backup/archival/retrieval activities in quality control laboratory
- Responsible for preparation and submission of audit response within stipulated timelines
- Responsible for providing of on the Job/CGMP trainings as and when required based on the requirements
- Responsible for approvals in LIMS, DMS, QAMS and Nichelon applications
- Responsible for manager activities in software based instruments as applicable as per the respective procedure
- Responsible for co-ordination with vendors/other GIL units on analytical method verification, analytical method validation or analytical method transfer requirements
- Review of column usage, working standard usage records and reconciliation
