Senior Executive Documentation CMCAnalytical

Review Analytical documents Protocols and Reports of Stability Analytical Method Validation
Analytical Method Verification and Analytical Method Transfer.
Recording deviations and findings taking corrective and preventive actions defined and implemented
in due time & trending of the various process nonconformance and OOS.
Support the regulatory compliance coordinator for the site to share all the necessary documents for
regulatory filings and annual updation.
Review of documents like SOP/Protocols/Schedules Spec/STPs/GTPs.
Verification of Stability Studies for Drug Products. (Verification of Stability samples Loading into Stability
chambers Daily withdrawal Monthly schedule and Verification of charging & withdrawal logbooks.
Monitoring performance of Laboratory Audit Trails.
To support the regulatory inspections like US FDA MHRA and other customer audits.
Check and ensure good documentation practices are followed.
Responsible for identifying the gaps and continuously improve the cGMP compliance in lab.
Monitor and ensure that all instruments and equipments are qualified before use.
Familiar with Analytical instruments & softwares like HPLC Chromeleon) UV (UV Probe) and Dissolution.
Responsible for timely review of release documents of raw materials and finished products.
Review and approve analytical instruments calibration reports.
To ensure effective documentation control process and archival of GMP related documents.
Review Stability Trend reports and certificate of analysis of drug products.
Training to new recruits and existing employees with respect to GLP/GDP systems followed in the organization or
any new system implemented.