vGMPsolv💊💊💊

Conducting of third party quality audits (GxP), vendor audits / supplier audits and external audits as per regulatory standards. Investigation of OOS, Deviation, Market complaint, Return good, OOT, OOE, Lab incidents, OOC & Data Integrity incidents, finding suitable root cause and proposing of effective CAPA. Implementation of cost saving, cost reduction, cost effective, process improvements in pharmaceuticals/ Life sciences / Healthcare firm's and decreasing the unnecessary load at work place. Conducting of various external & internal trainings as per effective training methodologies. Conducting of third party quality audits (GxP), vendor audits / supplier audits and external audits as per regulatory standards. Compilation & submission of various regulatory filings. Preparation and review of Quality risk assessment, Impact assessment and quality metric reports. Implementation of current guidelines (cGMP systems) at site level and as well as corporate level. Any time readiness for regulatory inspections, conducting of third party audits and external audits. Preparation of SMF, VMP, Protocols, SOPs, Documents & Quality plan. Conducting of route scouting (by R&D / ARD experts) & new product launching. Conducting of various validations & Qualifications. All Pharma related cGMP documents preparation and implementation. Preparation and review of Cleaning validation protocols & reports. Preparation and review of Equipment/ PW qualification protocols & reports (URS, DS,DQ, FS, RA, IQ, OQ & PQ). Preparation, Review of Process validation protocols & reports. Responsible for any GxP document preparation. Effective implementation of Change Control system. Closing of customer complaints with suitable investigation and CAPA. Participating / supporting in Regulatory, Internal & Customer audits. Review of QC/Micro dataSOPs, STPs, BCRs & BPCRs. Preparation, review (conducting) of transport validation protocols and reports. Implementation of QMS, Cpk, QbD, 5Ys, PLM, 5S, Kaizen, Sigma, Ishikava, FTA, FMECA, Cost saving, Cost reduction, cost effective & process improvement.