Summary
Overview
Work History
Education
Skills
References
Accomplishments
Certification
Work Availability
Languages
Timeline
Generic
Johnson Victor Dias

Johnson Victor Dias

Passionate Quality Professional
Navi Mumbai

Summary

Dynamic Quality Professional with extensive experience in Quality Management Systems and Regulatory Compliance, specializing in Quality Assurance and Analytical Research and Development within esteemed multinational organizations. Proven track record in implementing robust Quality Management Systems, conducting comprehensive audits, and ensuring compliance with industry standards. Expertise in vendor qualification, analytical method validation, technology transfer, CAPA, cGMP practices, and thorough investigations. Proficient in navigating complex challenges related to computer system validation, deviations, and out-of-specification/out-of-trend results to drive operational excellence.

Overview

21
21
years of professional experience
6
6
Certifications
3
3
Languages

Work History

Senior Manager, Quality Assurance

Encube Ethicals Pvt. Ltd.
03.2021 - Current
  • Conduct internal and external quality systems audits, and ensure the CAPA implementation.
  • Handling the investigations for deviations, OOS, OOT, RCI, and approving CAPA.
  • Support manufacturing plant-related investigations, market complaints.
  • Drive and implement continuous improvement projects.
  • Review and approval of risk assessment for nitrosamines, elemental impurities, and residual solvents.
  • Approval of AMV, AMT Protocol, and Reports.
  • Approval of Extractable and Leachable study, Nitrosamine, NDSRI protocols, and reports.
  • Evaluation of vendor documents (certifications, regulatory inspection history, and declarations - nitrosamines, elemental impurities, residual solvents, TSE/BSE, etc.).
  • Review and Approval of Product Development Report, POBMR, MFC, Stability, Q3 Protocol, and Report.
  • Review and approval of qualification, calibration protocols, and reports for instruments and equipment.
  • Digitization of the laboratory by implementing various software (Document, Learning, and QMS Management).
  • Approval of Computer System Validation documents.
  • Inspections and approvals of contract laboratories, service providers, and vendors.
  • Authorization of service contracts and technical agreements.
  • Support various divisions for effective and efficient implementation of the Quality Management System.
  • Lead the Quality Review Meeting with management.
  • Implemented and developed operational standards, policies and procedures.
  • Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
  • Improved team performance by providing comprehensive training and fostering a collaborative work environment.
  • Mentored junior staff members for skill development and career progression within the organization.
  • Achieved operational excellence by streamlining processes and implementing best practices.
  • Spearheaded change management efforts for the seamless adoption of new systems or processes.
  • Promoted a culture of continuous learning through regular workshops, seminars, and training sessions for staff.
  • Implemented risk management framework, mitigating potential threats to project success and company operations.

Manager, Quality Assurance

Enaltec Labs Pvt. Ltd.
02.2018 - 02.2021
  • Company Overview: Mumbai, Maharashtra, India.
  • Review and approval of analytical method validation protocol and reports (formulations, API, intermediates, and key starting materials).
  • Review and approval of the tech transfer protocol and report.
  • Accomplished multiple tasks within established timeframes.
  • Conduct internal and external quality systems audits, and the CAPA implementation.
  • Review and approval of qualification protocols and reports for instruments and equipment.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Calibration records review and approval. Release the sample review and approval.
  • To assist team members in compliance with quality systems, e.g. Change controls, incidences, deviations, customer complaints, etc.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Review and participation in Quality Management Review (QMR)
  • Conduct annual refresher trainings for cGMP, data integrity, and GDP.
  • Review and approval of computer system validation documents.
  • Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.
  • Authorization of service contracts and technical agreements.
  • QA Lead in the case of internal or external audits (customer audit or FDA audit).

Manager, Quality Assurance

Dr. Reddy’s Laboratories
09.2016 - 02.2018
  • Company Overview: Vizag, India. (FTO-9)
  • Review & Approval of Analytical Method Validation Protocol and Report for sterile products.
  • Review & Approval of Tech transfer Protocol and Report.
  • Review of Release and Stability Protocols and Data. Release in SAP system.
  • Assist in Internal and External Quality Systems Audits and the CAPA implementation.
  • Logging and handling the investigations for Incidents, OOS and providing CAPA for the same.
  • Review and approval of qualification protocols and reports for instruments and equipment.
  • Calibration records review.
  • To assist team members in compliance of quality systems e.g. change controls, incidences, customer complaints.
  • Rounds in the lab for compliance of GLP.
  • Auditing and Investigation Related Activities.
  • Provide support to the various divisions for effective and efficient implementation of the Quality Management System.

Executive R&D

Janssen Pharmaceutica, Pharmaceutical Companies of Johnson & Johnson Ltd.
05.2007 - 08.2016
  • Company Overview: India
  • Analytical Method development and validation for Assay & Degradation Products (Related Substances) of active ingredients in different types of formulations.
  • Dissolution Method development for Dissolution methods for QC-Release & stability testing and their validations as per current guidelines and regulatory requirements.
  • Start to end responsibility for a Projects (Method development, Optimization with locked formulations, Validation and Method Transfers for Dissolution Development & other analytical tests)
  • Working on NCE molecules for Analytical Method Development for Dissolution and pre-formulation studies.
  • Dissolution Method development for to support BA, BE and clinical studies and for IVIVC.
  • Exposure on Disso Development by using dissolution apparatus, USP-I, USP-II and USP-VII for different types of formulations and for all type of BCS class drugs.
  • Exposure on handling of various queries from different Health Authorities for the post approval changes.
  • Handling investigations, product and method related issues for the Life cycle management projects.
  • Multimedia Dissolution profiles, Comparison with innovator and f1&f2 calculations.
  • Data generation to support BA & BE studies and fulfill regulatory queries.
  • Preparation and reviewing of validation protocols for various types of analytical methods with respect to different formulations for Dissolution methods and other tests
  • Method Development on different formulations like different types of tablets, Capsules, powder for oral Suspensions and other formulations.
  • Calibration of Analytical Instruments like Dissolution Apparatus, HPLC and UPLC.
  • Use Electronic Lab note Book (eLN) for documentation.
  • Use of eLIMS.
  • Exposure on different soft-wares for the general usage of Analytical Instruments.
  • Preparation of SOP’s, Work Instruction and Best practice documents.
  • People management, work plan and work distribution and management of heavy work load.
  • Actively Participated in the USFDA, TGA, MHRA, EMA and other regulatory authorities.
  • Maintaining safe behavior while working, Participated in Behavior based safety program in collaboration with EHS.
  • Following all the standard operating procedures, cGMP and guidelines related to assigned work.

Junior Officer

Glenmark Generics Ltd
04.2005 - 04.2007
  • Company Overview: Colvale, Goa, India
  • Performing Assay, RS, Dissolution, Content Uniformity, Blend Uniformity for in-process and finished products by HPLC & UV techniques.
  • Performing Analytical method validations for dissolution, assay, content uniformity of Drug products.
  • Analysis for different formulations like tablets, Capsules, creams, ointments and other formulations.
  • Preparation of protocols for all types of Analytical methods like Assay active, degradation products, Content uniformity, Dissolution for all type formulations.
  • Development of dissolution discrimination methods for different types of formulations and changes in formulations.
  • Multimedia Dissolution profiles, Comparison with innovator and f1&f2 calculations.
  • Good Exposure on different soft-wares for the general usage of Analytical Instruments.

Trainee

Cipla Pharmaceuticals, Ltd.
08.2004 - 04.2005
  • Company Overview: Goa, India
  • Performing Stability studies for different types of dosage forms like Tablets, capsules, creams, solutions.
  • Stability testing for generic & ANDA drug products as per ICH guidelines.
  • Maintaining stability trend data and sample pull list.
  • Read and understand the in-house SOPs.
  • Understanding the ICH and FDA guidelines.

Education

Master of Science (M. Sc) - Organic Chemistry

Mumbai University
Mumbai, India
04.2004

Bachelor of Science (B. Sc) - Chemistry

Mumbai University
Mumbai, India
03.2002

H.S.S.C (XII) - Science

Fr. Agnel Multipurpose HSS
Verna, India
03.1999

S.S.C (X) - General Studies

St. Josephs Educational Institute
Chandor, India
03.1997

Skills

Troubleshooting and problem resolution

References

Dr. Yogesh, Swar, Ph.D.,  Janssen Pharmaceutical Companies of J&J, Head - SMMD, 

Mobile: +91-9820365942.

Dr. B.M. Rao, Ph.D., CEO - QDOT Associates, 

Mobile: +91-9347146701

Suresh Shitole, Sr. Vice President, APL Research Centre, Aurobindo Pharma Ltd., 

Mobile: +91-8806748848

Accomplishments

  • Lead Auditee (QA) during US-FDA inspection and Remote Regulatory Assessment (RRA).
  • Successfully Implemented Caliber Docs-IQ and Learn-IQ software at Encube R&D
  • Lead the computer system validation teams
  • Achievement award for significant contribution in Anti HIV project from Global Head (PDMS).
  • Several ENCORE awards for various projects.
  • Man of the series and man of the final match for J&J HIGI site cricket tournament-2011.
  • Got Onsite opportunity to work in Janssen Pharmaceutica, Beerse, Belgium on Dissolution Development on NME’s for six months.
  • Best All rounder for J&J HIGI site Volleyball tournament-2015

Certification

Generative AI Foundations Certificate

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Languages

English
Bilingual or Proficient (C2)
Hindi
Advanced (C1)
Marathi
Advanced (C1)

Timeline

Generative AI Foundations Certificate

07-2025

Six Sigma Foundation

09-2024

Operational Excellence Foundation

08-2024

Critical Thinking and Problem Solving

06-2024

Quality Management for Operational Excellence

06-2024

Senior Manager, Quality Assurance

Encube Ethicals Pvt. Ltd.
03.2021 - Current

Six Sigma: Green Belt

07-2020

Manager, Quality Assurance

Enaltec Labs Pvt. Ltd.
02.2018 - 02.2021

Manager, Quality Assurance

Dr. Reddy’s Laboratories
09.2016 - 02.2018

Executive R&D

Janssen Pharmaceutica, Pharmaceutical Companies of Johnson & Johnson Ltd.
05.2007 - 08.2016

Junior Officer

Glenmark Generics Ltd
04.2005 - 04.2007

Trainee

Cipla Pharmaceuticals, Ltd.
08.2004 - 04.2005

Master of Science (M. Sc) - Organic Chemistry

Mumbai University

Bachelor of Science (B. Sc) - Chemistry

Mumbai University

H.S.S.C (XII) - Science

Fr. Agnel Multipurpose HSS

S.S.C (X) - General Studies

St. Josephs Educational Institute

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Johnson Victor DiasPassionate Quality Professional