Prabhakar K.L

Experience

• 

  Ansell

  Nov 1996 - Mar 2015

  • To ensure Quality Management System compliance with regulatory requirements of ISO 9001, ISO 13485, MDD 93/42/EEC, US FDA CFR 21 Part 820 QSR and Schedule - M requirements. • Responsible for Handing Internal and External Quality audits.• To ensure that the company’s quality management system is implemented and maintained at all levels.• To conduct review on the quality management system.• To ensure timely corrective actions on all deficiencies found during internal or external audits.• Reporting on the performance of the quality management system to management for review to enable timely intervention and corrections.• Ensuring the promotion of awareness of regulatory & customer requirements throughout the Organization• The liaison with external parties and Notified bodies on matter relating to the Quality Management System• Responsible for Validations, Stability studies, licenses, quality system and product certifications etc.,• Responsible for license renewals, brand registrations, Free sale certificates, GMP certificate & etc with the local FDA.• Responsible Pre Qualification and registration process at various countries like Brazil, Peru, Europe, China etc.,Responsible for submission of documents for various tenders like UNFPA, SABS, GOI, PSI etc., • Liasing with regulatory bodies and external sampling / testing agencies like crown agents, Intertek, SGS etc., for organizing inspections Show less • To introduce & maintain the Quality System requirements of various applicable standards and ensure its compliance in all audits.• Responsible for Quality control and Quality Assurance function of the organization.• Ensure that calibration of manufacturing and lab equipment has been carried out as per schedule and the records are in place.• Ensure the implementation of good laboratory practices in the QA laboratory• Handling of customer complaints & feedback with CAPA & response.• Responsible for quality system documents, procedures and need of various standards applicable and train the resources to comply with the requirements.• Responsible for license renewals, brand registrations, Free sale certificates & etc with the local FDA.• Responsible Pre Qualification and registration process at various countries.• Responsible for monthly reports, KPI quality data, Product quality trends and Quality objectives.• Liasing with regulatory bodies and external sampling / testing agencies for organizing inspections Show less

  • Deputy Manager QA & RA

    Oct 2013 - Mar 2015

  • Asst. Manager QA & RA

    Jan 2008 - Sept 2013

  • Executive QA

    Jul 2006 - Jun 2008

  • Junior Executive QA

    Jul 2004 - Jun 2006

  • Operator

    Nov 1996 - Jun 2004
• 

  Sutures India Pvt. Ltd

  Apr 2015 - Jan 2016

  Assistant Manager QA

  Manufacturer of various types of Medical Devices

• 

  Berry Global, Inc.

  Jan 2016 - Feb 2020

  Asst Manager Quality & Regulatory

  Manufacturer of Pharmaceutical Packaging Containers, Closures Systems

• 

  LifeStyles Healthcare

  Feb 2020 - now

  • Senior Manager Quality

    Jan 2025 - now

  • Quality Control Manager

    Feb 2020 - Dec 2024