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Project Manager, quality engineer, validation specialist

Location:
Westland, MI, 48187
Salary:
60000
Posted:
October 27, 2011

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Resume:

OBJECTIVE: Looking for a position in an organization with challenging and stimulating environment that provides an ambiance for professional growth.

EDUCATION: Stevens Institute of Technology, Hoboken, NJ 12/09

Master of Science in Pharmaceutical Manufacturing Engineering GPA: 3.6

Major Subjects: Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Validation of Computerized System, Contemporary Concepts of pharmaceutical Validation, Regulation & Compliance in Pharma. , Introduction to Project Management, Bioprocess Technology in Pharmaceutical Manufacturing, Pharmaceutical Finishing and Packaging Systems–Solid Dosage, Good Manufacturing Practice (GMP) in Pharmaceutical Facilities Design, Introduction to Pharmaceutical Manufacturing.

Rajiv Gandhi University of Health Science, Bangalore, India

Bachelor of Pharmacy 12/06

Result: First Class

• Presented seminar on OPIUM, its uses and controls.

• Student Editor of Pharmaceutical magazine "Pharmazeal”

-The K.L.E college of pharmacy

• Performed experiments to study various toxicological effects analysis.

SKILLS: Data plotting and analysis, Statistics, Communication and Presentation, Problem Solving and Decision Making. Software Skills: Microsoft Office, Microsoft Project, Minitab, Microsoft Visio.

EXPERIENCE:

Caraco Pharmaceutical Laboratories, Ltd., MI, U.S.A.

Role: Supervisor, Quality Assurance Validation 02/10-Current

Responsibilities:

• Oversee, evaluate and define the specifications, requirements, challenges and activities to be included in process validation/verification.

• Perform all activities required for protocol execution.

• Perform, analyze, execute and evaluate all validation documentation for manufacturing, and packaging operations.

• Define specifications, requirements, challenges, and activities to be included in process validation/verification and, cleaning process validation/ verification studies.

• Oversee validation of production processes, perform statistical analysis, develop validation models, and write process validation protocols and final packages.

• Review incidents and deviations written by others, including Technical Services, Manufacturing/Packaging, and Quality Assurance, for technical content and applicability.

• Served as liaison/team member with QA, regulatory affairs, research and development, and manufacturing departments.

• Resolve all deviations/discrepancies encountered during protocol execution.

• Analyze all data collected during protocol execution, including statistical capability analysis.

• Evaluate the success of executed validation, verification, and qualification protocols, including recommendations and conclusions.

• Provide the technical input to assist with resolution of process challenges.

• Identify and implement quality and productivity improvements to manufacturing and packaging processes and equipment.

Ranbaxy Laboratory Ltd., India.

Role: Assistant Marketing Executive 09/07-12/07

Responsibilities:

• Performed survey on LAL test in order to market best new test facility.

• Provided information of new test to medical assistant and physicians.

• Arranged conference of leading physicians for introduction of new malarial test in 11/07.

Dr, Reddy’s Laboratory Ltd., India.

Role: QA Assistant 02/07- 08/07

Responsibilities:

• Assisted in various functions of Tablet Manufacturing such as weighing, mixing, blending, granulation, and packaging.

• Performed test on tablets including weight variation, CU and disintegration.

• Maintained and documented batch records.

View Laboratories Ltd., Gujarat, India.

Role: QA Assistant Intern 01/07 - 02/07

Responsibilities:

• Reviewed Batch Records.

• Inspected appropriate production of SOPs.

ACTIVITIES: Active member of International Society of Pharmaceutical Engineering (ISPE) and Indian Drug and Manufacturer’s Association (IDMA), Certified Professional Rescuer from Red Cross.

HOBBIES: Sports, Music, Electronic gadgets, traveling.

REFERENCES: Available upon request.



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