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Asst. Manager, Qa Resume

New, YorK

SUMMARY:

25 years’ experience of Medical, Pharmacology in different organization. Approximate 15 years’ experience as Physician, 7 - 8 years in Confidential, 3-4 years in Confidential . Perform very skillful & successful jobs in all facilities.

CORE COMPETENCIES :

  • Strong Analytical and Problem solving Skill. Work-flow Planning and Conflict Resolution
  • Strong organizational and decision making skills Documentation with FDA and ICH guide Process Improvements and Global Safety Leadership skills with Project coordination In-depth Knowledge of GCP, FDA, CFR. cGXPs knowledge in Reporting and analysis WHO drug dictionary& medical terminology Expert Case management & research abilities

TECHNICAL SKILLS:

  • Language: Fluent (read & write) in English, Bengali, Hindi and Urdu. Arabic (little)
  • Well conversant with popular packages i.e.MS Word, MS Excel, Power point, Internet, e-mail etc.

PROFESSIONAL EXPERIENCE:

Confidential, New York

Asst. Manager, QA

Responsibilities:

  • Created new cases, searched for duplicates and extracted info from the source documents for drug safety.,(Triage, Case Processing, and Quality Check).
  • Validated the expeditedness of the adverse events information using minimal criteria
  • Triaged the AEs using seriousness criteria for pre-marketed and spontaneous reports.
  • Checked promptly and accurately interpreted and entered serious and non-serious adverse events into the global database.
  • Supported the Pharmaceuticals management for Confidential in various activities such as review and/or submission of Med Watch forms, review of US Periodic Reports (PADERs), PBRER, PSURs and data entry into Confidential, & ARISg.
  • Performed Accurate coding of incoming serious and non-serious adverse events using Med DRA terminology and WHO-Drug Dictionary.
  • Assessed expectedness/listedness for all the AEs with respect to suspect drugs against Core Data Sheets (CDS), Investigative Brochures (IB) and Package Inserts (USPIs)
  • Created comprehensive narratives procured from related info from various sources
  • Reviewed, evaluated and summarized the information in a written document and initiated investigations if required.
  • Requested all pertinent follow up information from reporters for the completion of case reports within specific timelines as prescribed by global regulations and SOPs
  • Used internet or electronic databases to mail the inquiries and appropriately respond and to search for the published literature on the company products.
  • Made inbound letters received from consumers, healthcare professionals, and other manufacturers available in the central repository.
  • Assisted in signal detection activities preparation of aggregate reports like PSURs and Annual Safety Reports.
  • Efficiently performed periodic SAE reconciliation between drug safety and clinical trial database for ongoing clinical studies & performed QC of all serious AE cases.
  • Coordinated and worked with clinical data management team of various therapeutic areas to ensure quality deliverables for reconciliation in resolving discrepancies
  • Participated in the set-up and maintenance of adverse event workflow, monitoring department policies and standard operating procedures.
  • Performed electronic submissions and distributions of ICSRs to FDA and licensing partners. *Performed Quality Review of Individual Safety Case Reports (ICSRs) (including Literature articles) after reviewing of source documents with respect to seriousness, reporter/company causality, event resolution and listedness of Investigational and Post-Marketed products
  • Checked with well-versed with processed of SAE reconciliation against clinical data base
  • Reviewed PSURs and Annual safety reports and evaluated of signal detection activities
  • Assessed and implemented of clinical trial methodology, GCP and medical terminology
  • Participated in local and global project teams, including on-time delivery of assigned responsibilities.
  • Prepared, reviewed and control of standard operating procedures(SOP), review and control of validation protocols and master batch manufacturing and packaging records.
  • Evaluated the qualification of vendors of raw and packaging materials.
  • Sampled of raw materials, in-process materials and finished products.

Confidential, New York

Drug Safety Associate & Quality Assurance

Responsibilities:

  • Took care of manufacturing in process areas including Pharmacy, Milling, Blending, Compression. Pouching
  • Reviewed finished product specifications and standard operating procedures.
  • Proper documented and filed up, batch reviewed, prepared incident or observation report and corresponding.
  • Conducted regular meeting with all QAs and implement cGMP in all pharmaceutical operations
  • Performed Planning, monitoring and appraising job contributions of QA Inspectors.
  • Performed collection, processing, review and reporting of adverse events data in compliance with applicable FDA, and global regulations, and Company Standard Operating Procedures (SOPs)
  • Received and processed of AE/SAE reports (, spontaneous, literature and litigation), generate narratives, quality review and follow-up with clinical sites
  • Working in data entry including coding standards of incoming serious and non-serious adverse events using MedDRA terminology prescribed by global regulatory authorities.
  • Wrote comprehensive and concise safety narratives for clinical trial cases.
  • Performed Quality Review of Individual Safety Case Reports (ICSRs) (including Literature articles) after reviewing of source documents with respect to seriousness, reporter/company causality, event resolution and fistedness’ of Investigational and Post-Marketed products
  • Well versed with process of SAE reconciliation against clinical data base
  • Worked with, standard desktop computing programs, basic computer service principles and relational databases

Confidential, Long Island New-York

Senior Quality Assurance & Regulatory Affairs (including drug safety)

Responsibilities:

  • Prepared, review and control of standard operating procedures, review and control of validation protocols and master batch manufacturing and packaging records.
  • Performed and checked the state of systems compliance of manufacturing activities.
  • Evaluated the qualification of vendors of raw and packaging materials.
  • Sampled of raw materials, in-process materials and finished products.
  • Supervised and coordinated activities of Quality assurances employees, ensuring adherence to cGMPs and SOPs throughout the facility. *Planning, monitoring and appraising job contributions of QA Inspect
  • Performed and collected all necessary data from special projects:
  • Validation trials for updated manufacturing details, new products and equipment’s;
  • Annual performances qualification tests for all equipment’s
  • Annual and quarterly preventive maintenance records of all production machines.
  • Analyzing data collected from trials, tests and batch records for compression run-check-sheets, deriving conclusions to determine the release, return or rejection of trials and products.
  • Maintained the reserve samples of finished products and records of batch manufacturing, packaging and control records.
  • To maintain reserve samples of drug substances and excipients.
  • Acted as a liaison between QA department management and other Production management.
  • Assisted Production dept. in trouble shooting and root cause analysis investigations when required.
  • Assisted in writing investigation reports.
  • Reviewed finished product specifications and standard operating procedures
  • Checked dispensing and weighing of materials and for in- process quality checks.
  • Any other assignment allocated by the Section Head/Department Head.
  • Assisted Confidential Management in the oversight of deliverables related to ICSR case handling and calls for contributions for periodic reports including annual safety reports (ASR), development safety update reports (DSUR), Periodic Safety Update Reports (PSUR/PBRER/PADER), Risk Management Plans (RMP), Risk Evaluation and Mitigation Strategies (REMS) and other reports from the Drug Safety database
  • Served as mentor to other DSAs in interpreting and entering AEs into the safety database.
  • Ensured accuracy of coding of incoming AEs using terminology prescribed by global RAs in MedDRA, as prescribed by regulatory guidelines per WHO-DD coding, that drug trade names are correctly translated into INN (International Non-proprietary Name).
  • Created medically sound narratives procured from relevant and related information.
  • Worked with standard office paper, standard desktop computing programs, basic computer service principles and relational databases.

Confidential

Asst. Manager

Responsibilities:

  • Adhered to right first data entry principles, maintained quality of the cases, and minimized rework of cases
  • Identified and rectified discrepancies in the type of reports, clock start dates, and country of case corresponding with ADRM (Adverse Drug Reaction Monitoring).
  • Processed cases as per prioritization based on seriousness, method of receipt, literature translation, potential legal implications, and associated product complaints
  • Identified and processed the clinical trial cases that meet SUSAR reporting criteria, and facilitated medical review as per regulatory timelines
  • Experience in writing/responding to CAPAs
  • Served as mentor to other DSAs in interpreting and entering AEs into the safety database

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