Summary
Overview
Work History
Education
Skills
Languages
Timeline
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MANOJ BORSE

Fremont,California

Summary

Business-oriented Quality Control Manager trained to handle issues and remain level-headed at all times. Offering over 25 years of expertise overseeing quality control task for organizations in Pharmaceutical and cosmetic industry. An enthusiastic personality with skills in Quality control and Research and development.

Overview

27
27
years of professional experience

Work History

QUALITY CONTROL MANAGER

Allure Labs
Hayward, CA
01.2009 - 04.2024
  • Developed and implemented Quality Control policies and procedures.
  • Performed regular inspections of raw materials, components, and finished products.
  • Provided guidance on regulatory requirements related to Quality Control activities.
  • Collaborated closely with other departments to ensure high levels of customer satisfaction.
  • Assisted in developing new or improved processes to improve efficiency while maintaining quality standards.
  • Created inspection plans for incoming materials from suppliers.
  • Managed calibration systems for measuring equipment used in the production process.
  • Supported continuous improvement initiatives within the organization.
  • Analyzed quality control test results and provided feedback and interpretation to production management or staff.
  • Maintained records of test results, inspection findings, and corrective actions taken.
  • Prepared detailed reports on quality performance metrics for management review.
  • Trained staff on quality control principles, techniques, and processes.
  • Kept records of quality reports and statistical reviews.
  • Collected and analyzed production samples to evaluate quality.
  • Troubleshot product issues and fixed problems.
  • Conducted internal audits to ensure compliance with ISO 9001 standards.
  • Analyzed data to identify areas for improvement in the quality system.

R&D Executive

Johnson & Johnson
Mumbai, Maharashtra
12.2007 - 06.2024
  • Designed test plans and protocols for new products under development.
  • Led team meetings, project reviews, and status updates with senior management staff.
  • Developed training materials for new employees in the R&D department.
  • Completed regulatory documents concerning safety issues.
  • Calibrated scientific or technical equipment.
  • Coordinated with cross-functional teams to ensure successful product launches.
  • Identified areas for process improvement within the R&D department.
  • Finished projects on time and within budget.
  • Created accurate project specifications, documenting in technical manuals.
  • Fulfilled projects by planning, budgeting and coordinating projects.

Senior Pharmaceutical Analyst

Kotra Pharma SDN BHD
Meleka, Malaysia
07.2008 - 11.2008
  • Conducted laboratory experiments to analyze the efficacy of pharmaceutical products.
  • Developed batch records, method development documents, and product specifications for new drugs.
  • Performed data analysis and validation of pharmaceuticals to ensure compliance with regulatory standards.
  • Analyzed test results to identify potential issues with drug formulations or production methods.
  • Maintained records of analytical testing activities and prepared reports for review by senior management personnel.
  • Assisted in developing SOPs related to analytical testing procedures for new drugs and products.
  • Provided technical support to other departments regarding drug stability evaluations and release protocols.
  • Prepared samples for analysis using various techniques such as HPLC, GC, FTIR.
  • Investigated customer complaints concerning product quality issues or discrepancies between batches.
  • Audited documentation from vendors prior to procurement of raw materials used in drug production.
  • Ensured that all laboratory equipment was properly maintained according to safety regulations.
  • Verified functionality and accurate calibration of laboratory equipment, spectrometers and chromatographs.
  • Trained junior staff members on proper use of laboratory instruments and standard operating procedures.
  • Analyzed finished products for pharmaceutical industry using different methods.
  • Recorded and calculated analytical results on spreadsheets, enabling sharing with other scientists.
  • Managed laboratory personnel and monitored team performance and work quality.

Quality Assurance Executive

GlaxoSmithKline Pharmaceuticals
Nashik , Maharashtra
08.1997 - 11.2007
  • Supervised a team of Quality Assurance Technicians in the development and execution of testing plans.
  • Analyzed test results to determine root cause analysis and corrective action plans.
  • Created detailed reports summarizing audit findings and recommended corrective actions.
  • Coordinated with internal departments to ensure timely resolution of quality issues.
  • Established criteria for acceptance or rejection of materials based on customer requirements.
  • Investigated customer complaints related to product defects or non-conformances identified during production operations.
  • Supervised and guided inspectors, technicians and other staff.
  • Established procedures and quality standards.
  • Troubleshot product issues and fixed problems.
  • Met project scope and delivery dates by planning optimal testing schedules.

Education

Master of Science - Analytical Chemistry

KTHM College
University Of Pune
08-1997

Skills

  • Compliance understanding
  • Quality processes
  • Operational Improvements
  • Budget Preparation
  • Quality Control
  • Documentation Control
  • Regulatory knowledge
  • Lean Manufacturing Methodologies
  • Staff Supervision
  • Performance monitoring
  • GAMP systems expert
  • Critical Thinking
  • Knowledge of auditing systems
  • Effective Communication
  • Specification Development
  • Decision-Making
  • Analytical Thinking
  • Problem-solving aptitude
  • Team building

Languages

English
Professional
Marathi
Professional
Hindi
Professional

Timeline

QUALITY CONTROL MANAGER

Allure Labs
01.2009 - 04.2024

Senior Pharmaceutical Analyst

Kotra Pharma SDN BHD
07.2008 - 11.2008

R&D Executive

Johnson & Johnson
12.2007 - 06.2024

Quality Assurance Executive

GlaxoSmithKline Pharmaceuticals
08.1997 - 11.2007

Master of Science - Analytical Chemistry

KTHM College

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MANOJ BORSE