Assistant manager CQA

Exposure to Drug Product Outsourcing Manufacturing Site GMP Audit &  New Outsourced Products Documents Assessment is must. 

• Conduct Outsourcing Manufacturing Site (CMO) GMP Audit/ API Vendor Audit independently. Prepare inspection report & review of compliance report.
• New Outsourced Products documents Assessment/Approvals. Review of Site documents and Product specific documents.
• Monitoring of Approved CMO through periodic Audits/Visits to Site/Product compliance status.
• Exposure to Quality Management Systems (QMS) & documentation
• Loan Licence Site Product Tech Transfer documentation activity
• Preparation/revision of SOPs, preparation of Master documents preparation & other CQA documentations.
• Experience in preparation, review of investigations of Product complaints with effective data analytics and appropriate CAPA.
• Knowledge of In-process quality assurance (IPQA), shop floor QA monitoring, manufacturing and packing activities and batch release.
• Knowledge of Process validation, cleaning validation, HVAC Qualification, equipment qualification, Water system Qualification and QC functions etc.
• Monitoring of CFA through periodic Audit/Visits
• Knowledge of SAP Activity- FG Code creation, PM Code creation, RM/PM BOM creation/revision.
• Knowledge of regulatory guidelines i.e. WHO-GMP Guidelines, D&C Act, ICH Guidelines, EU/PIC/s Guidelines, FSSAI, Schedule T and other relative guidelines.