Summary
Overview
Work History
Education
Skills
Timeline
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Nitin Arankalle

Nitin Arankalle

Biopharma
PUNE

Summary

Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills. Thorough Quality Assurance Specialist with Number-year background in Industry. Excellent resource management and allocation skills. Outstanding communication, organizational and time management talents.

Overview

14
14
years of professional experience
9
9
years of post-secondary education

Work History

Quality Assurance Specialist In QMS

Serum Institute Of India Pvt. Ltd.
PUNE
08.2012 - Current
  • Monitored product standards and quality-control programs.
  • Fixed identified issues to increase productivity and boost workflows.
  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
  • Liaised with vendors and end-users to uncover system optimization opportunities.
  • Addressed non-conformance issues, pausing production to correct errors.
  • Analyzed quality and performance data to support operational decision-making.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Promoted adherence to quality standards by educating personnel on quality control.
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Performed standard first article inspections and random sampling inspections to verify adherence to customer standards.
  • Fixed identified issues to improve workflows.
  • Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
  • Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
  • Conducted investigations into questionable test results.
  • Assessed products or services to evaluate conformance with quality standards.
  • Performed tests and inspections to conform to established standards.
  • Reviewed production processes and identified potential quality issues.
  • Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
  • Collected and analyzed data to measure effectiveness of quality control processes.
  • Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
  • Developed and implemented procedures to meet product quality standards.
  • Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
  • Reported problems and concerns to management.
  • Drafted technical documents such as deviation reports, testing protocol and trend analyses.
  • Inspected items and compared against standards to meet regulatory requirements.
  • Conducted data review and followed standard practices to find solutions.
  • Recorded and organized test data for report generation and analysis.
  • Created testing protocols to be used across product lines.

Quality Analyst

Emcure Pharma
PUNE
12.2011 - 08.2012
  • Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Developed and maintained quality assurance procedure documentation.
  • Monitored KPIs to proactively address bottlenecks and quality issues.

Quality Analyst

Fresenius Kabi
PUNE
06.2011 - 12.2011
  • Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.

Quality Analyst

Cipla Ltd.
Goa
09.2009 - 06.2011
  • Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.

Education

M. Sc. - Microbiology And Immunology

Waghire College Saswad
Saswad
06.2007 - 07.2009

HSC - Science Education

Sadhana Vidyalaya
Pune
06.2000 - 06.2004

B.Sc. Microbiology - Microbiology And Immunology

Annasaheb Magar College
Pune
07.2004 - 06.2007

Skills

Correction action planning

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Timeline

Quality Assurance Specialist In QMS

Serum Institute Of India Pvt. Ltd.
08.2012 - Current

Quality Analyst

Emcure Pharma
12.2011 - 08.2012

Quality Analyst

Fresenius Kabi
06.2011 - 12.2011

Quality Analyst

Cipla Ltd.
09.2009 - 06.2011

M. Sc. - Microbiology And Immunology

Waghire College Saswad
06.2007 - 07.2009

B.Sc. Microbiology - Microbiology And Immunology

Annasaheb Magar College
07.2004 - 06.2007

HSC - Science Education

Sadhana Vidyalaya
06.2000 - 06.2004

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Nitin ArankalleBiopharma