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Qa Associate Resume

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PROFESSIONAL SUMMARY

A self motivated individual with over 4 years of Pharmaceutical experience in manufacturing, packaging, inspection and quality assurance with cGMP. Possess excellent ability to develop rapport and build trusting relationships within all levels of organization. A quick learner with problem solving ability and achieved great success in Masters in Pharmaceutical Manufacturing Engineering with GPA of 3.6 through persistent hard work

  • A Licensed Pharmacist in India
  • Certified Pharmacy Technician and Quality Improvement Associate in USA

WORK EXPERIENCE

Confidential, Oct '10-present
Assistant Supervisor and Quality Inspection Lead

  • Member of Safety Committee andsafety lead for packaging
  • Performs quality inspection on syringes and their documentation
  • Documentation specialist in terms of planning and inventory
  • Uses MRP system to enter work orders and access batch information
  • Writes and updates SOPs, modules for training
  • Reviews and tracks closure of Change Control, CAPA and NCR investigations in Track Wise
  • Uses Risk Assessment, Root cause and Trend Analysis as tools for investigations or deviations
  • Vendor Qualification
  • Compliant Handling
Confidential, INDIAJan '07-Jun '08

QA Associate -Manufacturing and Compliance

  • Performed documentation review for compliance and audit
  • Engaged in updating and writing BMR, BPR, log books and SOP's
  • Carried out inspection of vial filling, water and powder sampling, sealing and packaging
  • Performed checks on incoming raw materials and components
  • Released products for commercial distribution
  • Participated in Annual Product Reviews and Internal Audits
  • Gowning certified

INTERNSHIP EXPERIENCE

Confidential, INDIA
Clinical Research Scientist

  • Engaged in daily ward round participation and patient case studies
  • Performed ward rounds with the doctor in-charge
  • Observed live operation of laryngectomy in OT with doctors-surgery and anesthesia specialists
  • Given presentations on Alzheimer's disease and Patient Medication history
EDUCATION

MS in Pharmaceutical Manufacturing Engineering,Stevens Institute of Technology
Course Content:

  • Validation and Regulatory Affairs, Project management
  • GMP in pharmaceutical facilities design, Pharmaceutical Finishing and Packaging Systems
  • Medical Devices Manufacturing and Process Analytical Technology

Skills:

  • Validation Master Plan, Process Analytical Technology and Six Sigma
  • 21 CFR Part 11, 210, 211 & 820 and ICH guidelines

Bachelor of Pharmacy Honors Program
Course Content:

  • Associate degree in Clinical Pharmacy
  • Pharmacotherapeutics and Pharmacoeconomics
  • Drug Regulatory Affairs and Clinical Pharmacy Practice

Skills:

  • Performed Research on Psychiatric drugs and diseases

Bachelor of Pharmacy
Course Content:

  • Pharmaceutics, Pharmacology and Pathopyhsiology
  • Chemistry-Organic, Inorganic and Medicinal
  • Biotechnology and Microbiology

Lab Work:

  • Analysis and Chemistry-Organic and Inorganic
  • Well skilled in all chromatographic techniques including HPLC, TLC and GC
  • Performed disintegration, dissolution, hardness and friability tests on tablets

Skills:

  • Awarded as the Best Student in Medicinal Chemistry
  • Performed Experiments on guinea pigs, rabbits, rats and mice
  • Performed tests on Cell Culture and growth of micro-organisms
  • Animal Handling

AFFILIATION

  • MEMBER OF ISPE
  • Visited INTERPHEX 2009

COMPETENCIES AND SKILLS

  • Safety minded and a good communicator with computer skills in Microsoft Office and Visio
  • Comfortable in interacting with all levels organization and public
  • Strong verbal, listening and writing skills
  • Excellent problem solving ability and able to make decisions independently and quickly with minimal escalations

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