Summary
Overview
Work History
Education
Skills
Timeline
Hi, I’m

PRINCY M

Manager
Bangalore,Karnataka

Summary

Seeking Senior level assignments in the domain of compliance and sustainability with an organization of high repute Brief overview A result-oriented professional with over 14 years of experience in quality management compliance, coordinating with the team and enhancing process operations in the field of Synthetic Organic Chemistry and Medicinal Chemistry. Key strength: Making and managing of project proposals Designing synthetic methodology Strategic planning Leadership and team building Training and skill development Synthetic organic chemistry Review and approval of data Quality management systems Safety audits PPT presentations Teleconference Career scan Currently working as a Team Leader in Discovery Chemistry department of Syngene International Ltd., Bangalore (A Biocon Company). CAREER OUTLOOK: 11 Years of rich experience in various Quality Management Systems: QC, QA and Compliance. Rich experience in Analytical and Electronic data review and approval. Preparation and approval of customer requirements and specifications. QMS audit support for client requirements. Profound in handling Investigations, Deviations and Change control as per GMP practices. Master in review and approval of Analytical method validation reports. Profound knowledge in handling ISO 9001, ISO 14001 and ISO 45001 audits. Proficient in conducting internal audits and lab compliance. Skilled in coordinating Training and development. Profound documentation knowledge for ISO, IMS and GMP requirements. Compliance management for REACH, ECHA, ZDHC, ECO PASSPORT and Blue sign. Team building and presentation skill. Experience in dealing with different business verticals and units. Pursuing Certified Quality Auditor certification under ASQ (American society for Quality).

Overview

15
years of professional experience

Work History

Resil Chemicals

Manager
01.2020 - Current

Job overview

  • Integrated Compliance and sustainability under the QA

DSK InnoSciences Pvt. Ltd

Deputy Manager, CRO
04.2019 - 11.2019

Job overview

  • For the implementation of QMS for the
  • Worked at Apotex pharmachem in Quality dept
  • For more than 9 years, Developmental Quality Assurance:
  • Adept at managing documentations as per pharmaceutical industry regulations and ICH Guidelines
  • Adept at managing documentations as per ISO 9001,ISO 14001and ISO 45000 guidelines
  • Review and approval of all analytical reports generated in accordance with the corresponding STP and industrial guide lines
  • Review and Approval of Standard Operating Procedures and Standard Testing Procedures through Change control
  • Auditing various sections of QC like Stability, R&D lab, Reference Standards and Raw Materials
  • Dealing with various antimicrobial certifications and regulations
  • Project presentations and QMS presentations
  • Actively participated in the USFDA, Health Canada, TGA and customer audits as SME (Subject Matter Expert)
  • Follow up of External and Internal audit observations and ensuring the completion and effectiveness of CAPA activity if any, within the timeline
  • Audit preparation activities, Planning, Monitoring and Execution of GLP Activities
  • Approval of Certificate of Analysis which includes batch release, shelf-life extension, method change or any specification change
  • Approval of analytical method validations and their protocol
  • Review of various deviations, investigations and change controls through trackwise
  • Quality Control:
  • Review of all analytical and electronic data
  • Preparation and review of Standard Operating Procedures, Standard Testing Procedures, Protocols and Work instruction through Change control
  • Preparation and Monitoring of master calibration schedule of all instruments and equipment
  • Recertification of analytical standards and their inventory management
  • Coordinate with the QA and QC for implementation of the current / revised standard testing procedures and specifications for new products
  • Have exposure in various sections of QC like Raw materials, In-process, Intermediates, Finished products
  • Review of relevant Monographs, Technology Transfer Packages and MBPCR
  • Trainings and course
  • Coordinating and maintaining Trainings for new entrants as per guidelines and Standard Operating Procedures
  • Preparation of Training Metrics which helps to identify the training requirements for the existing employees on the Instrument related techniques
  • Undergone several training programs on cGLP, cGMP, GDP & ICH requirements, especially to meet and cope up with the changing regulatory scenario.

Apotex Pharmachem India Pvt.Ltd.

Senior Executive
01.2009 - 03.2019

Job overview

Education

School of Chemical Sciences
Kannur University Campus

Master of Science from Chemistry
04.2005

University Overview

Kannur University
Kannur University

Bachelor of Science from Chemistry
2002

University Overview

ASQ
ASQ

CQA_Lead Auditor
12.2023 - Current

University Overview

Skills

  • IT Skills:
  • Overview of LIMS software, ERP and SAP
  • Well versed with Power point presentations
  • MS Office, MS Excel, MS Word

Timeline

ASQ
CQA_Lead Auditor
12.2023 - Current
Manager
Resil Chemicals
01.2020 - Current
Deputy Manager, CRO
DSK InnoSciences Pvt. Ltd
04.2019 - 11.2019
Senior Executive
Apotex Pharmachem India Pvt.Ltd.
01.2009 - 03.2019
School of Chemical Sciences
Master of Science from Chemistry
Kannur University
Bachelor of Science from Chemistry
PRINCY MManager