Planning /Execution: Monitoring the planning and execution of the routine analytical activities to cater smooth and timely analysis.Review :Responsible for the timely review and analytical documents pertaining to cleaning validation, process validation, In process, finished and stability sample analysis.QMS : Leading the Quality Management Front w.r.t timely closures and adequate root cause analysis and effectiveness in the CAPA closures.Regulatory Inspections: Leading the audits from the front and supporting for the adequate explanations of the procedures and handling the auditor’s queries and preparing the regulatory responses.Regulatory Filings:Catering to the regulatory filings and required analytical document support.Good Lab Practices: Supporting the good laboratory practices w.r.t timely availability of the approved documents (protocols and procedures) as well as meeting the analytical requirements w.r.t columns, standards, chemicals.

QC analytical activities. QMS handling