As a Clinical QA Auditor (Lead) and PV QA team member my job role is Auditing & Quality monitoring of BA/BE and Clinical Studies.CRO qualifications for Clinical and PV functions. And driving application/ projects to comply with CSA at CQA BioconAlso Quality DI Auditor for performing DI audits across the sites of Biocon Limited and Biocon Pharma Limited

CSV & CSA I VALIDATIONS & QUALIFICATIONS I DATA INTEGRITY ASSURANCE I AUDITS & COMPLIANCE I GXP I RISK MANAGMENT I SOFTWARE QUALIFICATIONS I AUDITING I LEARNING & DEVELOPMENT I TRAINING I QMS I VENDOR HANDLING I TEAM MANAGMENT & COLLABARATION I STRATEGIC THINKING

Skills: Learning and Development Management , Verification and Validation (V&V) of Software, Regulatory Audits, GxP, Computerized Systems Validation (CSV), 21 CFR Verification, SAP SF vLMS, Document Management Systems (DMS), QMS, Problem Solving, Risk Analysis, Risk Management, People Training & Development, Operational Excellence, Compliance Management, BABE Monitoring, CRO Audits & Qualifications

In Quality Assurance Department at Biocon Limited (Generic formulations OSD, Complex Injectables with Devices)Digital initiatives implementations, Handling QMS systems, Track Wise, PDR, DHF, Vendor audits of CRO & CTL and vendor qualifications, product filling to various geographies and CRL Query response, Quality front handling of method transfer, validation, batch technology monitoring at inhouse and CMO sites for analytical and formulation process, audits and compliance, Self inspection.

General QA:  Preparation of CPV on quarterly basis, APQR, SOPs, aseptic process simulation study documents as per GMP. Review and trending handling of QMS, executed batch documents, validation documents Document and training management Handling of calibration, performance verification and PM (Internal & external teams) Handling of QA documentation archival & retrieval system.IPQA Activities: Handling of all IPQA activities of sterile SVP cytotoxic injectable drugs in all stages To ensure cleanliness and sanitation of manufacturing area, aseptic practices and environmental conditions are maintained in respective area of the operation. Handling of line clearance and batch execution monitoring at various steps of batch process and packaging. Clearance for finished goods dispatch from warehouse for various geographies.  Handling / inventory of control samples, Semi-Finished samples and finished goods samples. Lead / In Charge of aseptic process simulation studies.  Execution of Packaging line validation & IPQA activities. Review and approval of monthly documents at shop floor and in laboratory area.  As a QA validation team have done validation and qualification of area and process of new project PLD (Pegylated Liposomal Doxorubicin, with a feature of targeted drug delivery mechanism, having complete closed system of manufacturing operated through SCADA systems without man interruption to maintain sterility)

Quality Assurance Department: Preparation of APQR, SOP, Process validation and cleaning validation protocols  Documentation, training and QMS management and trending Handling of market complaint samples Review and compilation of BMR and BPR’S Preparation and follow ups for calibration of instruments and machinery in QC and production Review and tracking of closure of deviations, non-conformances, OOS, OOT and corrective actionsIPQA Activities: To ensure environmental conditions, cleanliness and sanitation of manufacturing area. Handling of line clearance at all stages of LVP and SVP. Batch release & clearance for finished goods dispatch to various regions of GCC.  Handling of all IPQA activities of sterile LVP and SVP lines. Calibration & PM management for QA & QC department Reservice sample management.Quality control Department: Standard procedures preparation for QC Preparation of monthly and annual trend of water system and clean rooms monitoring  Method of analysis preparations of all microbiological testing methods Conducting trainings and maintaining training files, analyst qualifications Sampling and analysis of RM, IP, Finished product and stability samples Performance of sterility testing, Bacterial Endotoxin Test, MLT, water samples testing, media preparation  and GPT, handling of pure culture, subculture and isolates, biological indicators and endotoxin indicators Analyzing and assuring label claim sensitivity and growth promotion tests upon receiptQualifications and validations: Process & Cleaning validation for LVP and SVP products Qualification of lab instruments (autoclave, LAF, TOC, Incubators, sterility testing instrument- Equinox) Water system qualification Phase 1, 2 and 3, disinfectant qualification, analyst qualification, area qualification by Non-viable particle count and viable monitoring Analytical instruments handled (Potentiometer (Metrohm), Polarimeter (Atago), HPLC (Agillent technologies)

 Microbial Limit Test / Bioburden of Raw materials, bulk, in process, finished, stability samples Preservative efficacy test of finished products, stability samples and control samples Microbiological assay by cup plate method (Neomycin, B12, Bacitracin, Polymyxin B, Chloramphenicol) Management of various activities in micro department like media, culture, sampling Documentation & review of trends, water reports, EM reports Calibration, Verification and analysis of Auto pipettes, pH and Conductivity TOC (Total Organic Carbon) Analysis, 2 point and 4-point calibration (Make: Shimadzu)  Involved in sterility testing by direct inoculation method, membrane filtration method (bulk vaccine samples, lyophilized samples after filling) Qualifications and validations: MLT method validations, autoclave qualification Filling validation sample analysis, cleaning validation sample analysis, disinfectant validation, UV efficacy study  Area qualification and Plate exposure timing for area monitoring & Water plant Qualification(In classified areas by environmental monitoring)

 Microbial Limit Test / Bioburden of Raw materials, bulk, in process, finished, stability samples Preservative efficacy test of finished products, stability samples and control samples Microbiological assay by cup plate method (Neomycin, B12, Bacitracin, Polymyxin B, Chloramphenicol) Management of various activities in micro department like media, culture, sampling Documentation & review of trends, water reports, EM reports Calibration, Verification and analysis of Auto pipettes, pH and Conductivity TOC (Total Organic Carbon) Analysis, 2 point and 4-point calibration (Make: Shimadzu)  Involved in sterility testing by direct inoculation method, membrane filtration method (bulk vaccine samples, lyophilized samples after filling) Qualifications and validations: MLT method validations, autoclave qualification Filling validation sample analysis, cleaning validation sample analysis, disinfectant validation, UV efficacy study  Area qualification and Plate exposure timing for area monitoring & Water plant Qualification(In classified areas by environmental monitoring)