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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLEHonest, hardworking and detailed oriented Quality Control & Quality Assurance professional with 6+ years of QA/QC/Audit/Regulatory Affairs experience with multinational pharmaceutical companies is seeking career opportunity in an organization where growth is a way of life.Education:Long Island University, Brooklyn, New York. Aug 2022 - PursuingMS in Pharmacy (Drug Regulatory Affairs; CGPA: 3.9/4.0)Parul University, Gujarat, India. Aug 2012 May 2016Bachelor of Pharmacy (B.Pharm; CGPA: 7.9/10.0)Expertise/Skills:Quality management system (QMS) Software: SAP, Caliber QMS, DMS, QUAMS, Track wise, LIMS, Schedule manager.Laboratory Instruments: HPLC & GC, UV & FTIR Spectrophotometer, Malvern Particle Size Analyzer, Karl Fischer & Auto-Titrator, Refractometer, Polarimeter, Analytical & Ultra Micro Balance, pH Meter, HPTLC/TLC System, Tap Density Tester and Turbidity meter.Computer: Microsoft word, Microsoft Excel, Microsoft power point.Familiar with FDA, ICH, GDP, GMP/GLP guidelines, ALCOA++ and Safety Guideline.Audit faced: FDA, Virtual USFDA, COFEPRIS(Mexico), WHO-GMP, Internal and corporate audits, 20+ customers site audits.Professional Experience:LUPIN Limited, India (USFDA, MHRA, TGA, ISRS WHO GMP certified) Feb 2021 Aug 2022Quality Assurances Officer (QC Documentation & QMS Section)Responsible for QC change controls, CAPA, effectiveness check actions & QRM through Caliber QMS software by collaborating with production, regulatory affairs, analytical development lab and R&D departments to achieve quality control objectives and its compliance. Accordingly, responsible for preparation of new or update QC specifications & its respective test data sheet (FP, INT, IP, RS, RM & PM), SOP & COA through SAP and also stability protocols & hold time protocols through Document management (DMS) software.Gained hands-on knowledge about manufacturing process and packaging configuration of respective drug substance (API) from BMR or BPR.Provided on-the-job training to new recruits as and when required.IPCA Laboratory Ltd, India (CDSCO, COFEPRIS (Mexico), WHO certified) Aug 2016 Feb 2021Quality Control Officer (GLP Section)Responsible for perform calibration & preventive maintenance of all QC instruments along with its schedules by using schedule manager software; Reviewed & maintained the daily calibration records of QC instruments; Maintained HPLC & GC Columns stock; Responsible to trained department members in regards to SOP revision and imparted other trainings, orientation and analyst qualification to new recruits and its documentations.Involved in preparation of investigation reports related to lab Incidence, System suitability failures (SST), Deviation, OOS & OOT of QC lab; Actively participate in troubleshooting of QC instruments; Responsible to check audit trails and investigated the project integrity failure report of Empower 3 software for HPLC/GC instruments; Responsible for reporting the monthly status of all QC activity.Involved in all customers, corporate, internal audits as an Auditee and prepared the audit compliance report for it.Handled & monitored QC change controls, CAPA, effectiveness check monitoring and deviation through Track wise Software; investigated the deviation and initiated CAPA, if required.Responsible for preparation of all QC master documents i.e. specifications, analytical templates, GTP, QRM, protocols & reports for Analytical method validation, verification, and AMT; Prepared, reviewed and updated QC SOP; Prepared COA as per Customer requirement of FP, INT & RM.Performed analysis of FP, INT, IP, RM, PM samples whenever required; Maintained external sample analysis records.Professional Activities:Industrial Training: Sun Pharma Advanced Research Center (SPARC) and KAPTAB Pharmaceutical.Site Visit: Zydus Cadila Healthcare Ltd., Vital Healthcare pharmaceutical and Sunvij Drugs Ltd.Training seminar of Agilent on Compliance & Data Integrity in January 2019.Attended international conference on Advances in formulation development: challenges and applications in March 2016. |
