At S Zhaveri Pharmakem Pvt Ltd (Crescent Pharma), I administer MasterControl QMS workflows for CAPAs, change controls, deviations, and SOPs. I also manage user access and coordinate training for the new site implementation.
I oversee quality system activities and conduct or support audits of CMOs, vendors, and internal sites. I also participate in regulatory inspections and oversee warehouse temperature monitoring and mapping programs.
At M J Biopharm Private Limited, I directed the Vendor Management System, coordinating manufacturing audits and reviewing vendor questionnaires, audit reports, and Quality Technical Agreements. I also coordinated change controls and supported audit readiness and vendor qualification.
Earlier, at CIPLA Limited, I reviewed manufacturing, filling, and packing records, investigated non-conformances, and prepared Annual Product Quality Reviews. At Wockhardt Limited, I supported document control, batch document review, SOP updates, APQR, and IPQA operations.
