Site Audit and Compliance and Specification and STP, Test data sheet, Stability protocol, GLP monitoring, Method validation , verification, transfer, Microbiology method suitability, Qualification of Instrument and Equipments, method equivalence, QC audit trail review

Documentation,BPR preparation and approval,indenting BOM , packing section , Handling of reactors , MEE , water plant ,centrifuge, kiln, Blenders, raw material and packing material

BPR review, analytical record review , shoop floor compliance as per SOP ,preparation of SOP .

Site validation and Qualification , Corporate Quality compliance,Process Validation,Cleaning vaidation,Hold Time ,Water ,Nitrogen,Compresses Air,ONcology,PLC, SCADA,Variability Matrix,CSV,Change control

APQR,validation protocol and reports,equipment qualification, change controls,CAPA, compliance,stability , cleaning validation, Qa release,exhibit, pre-exhibit approvals, Qc test data review, quality comparison,Quality risk management,water system qualification,return goods, HVAC revalidation,conditional release,Material master approval,stock transfer ,return goods and market compliants,master BPR approval ,process validation,RLAF qualification, WInds system, WMS system,SOP preparation and review,Nitrogen system requalification,micro validation,thermo-cyclic study, Batch disposition tracking,deviation,line clearance, Maco risk analysis based on ADE,Sampling of finished good material .reprocess of material , code to code transfer if material Micro & Analytical method validation tracking in Manufacturing assurance.Risk assesment in RLAF for FP,Micro validation

Data integrity team, IPQA for all the cross functional team such as Eng, Warehouse, Production , QC, R&D

Validation,change control , deviations, Qa release/ dispatch , QMS,ARR,Documentation and archivel,Manufacturing assurance ,Training co- ordinater, SOP review and Approval,Equipment qualification, analytical instrument qualification, OOS/OOT,self inspection,SMF , BPR/ eBPR review , DCS/MES systems, cGMP compliance,HVAC, water qualification,process validation,Quality matrix,Quality manual,computer system validation