Pari
Vendor Development Trainer in Bengaluru
- ISO 9001:2015 Lead Auditor
- Lean Six Sigma Black Belt
- Quality Management Systems
- Regulatory Compliances
- Vendor Development
- Remediation & Risk Management
- Policy Formulation & Implementations
- ESG
- Location
- Bengaluru, India
- Trainer Since
- May, 2016
Vendor Development Trainer in Bengaluru
About Pari
Subash is a seasoned and highly proficient trainer with expertise in various critical areas, including Quality Management Systems, Computer System Validation, Regulatory Compliances, Data Integrity, Inspections & Audits, Technology & Site Transfer, Vendor Development, Remediation & Risk Management, Policy Formulation & Implementations, Process Validation, Automation, Digitization, E-LIMS (Electronic Laboratory Information Management System), and E-QMS (Electronic Quality Management System). With over 20+ years of extensive work experience, he has established himself as an authority in these essential domains of quality assurance, compliance, and technology integration. His training programs are designed to empower individuals and organizations with the knowledge and skills necessary to excel in regulated industries.
His impressive 20+ years of professional experience highlight his unwavering commitment to ensuring quality, compliance, and technological advancement in regulated industries such as pharmaceuticals, healthcare, and manufacturing. His diverse skill set and deep expertise make him a highly sought-after resource in industries where adherence to regulations and quality standards is paramount.
As a trainer, he specializes in Quality Management Systems, equipping professionals with the knowledge and tools needed to establish and maintain robust quality assurance processes. His expertise in Computer System Validation ensures that individuals understand the intricacies of validating computerized systems in regulated environments.
His is well-versed in Regulatory Compliances, guiding individuals on how to navigate the complex landscape of regulatory requirements and inspections. His focus on Data Integrity, Inspections & Audits prepares professionals for successful regulatory audits and inspections.
In addition to compliance and quality, he provides training in cutting-edge technology areas, including Automation, Digitization, E-LIMS, and E-QMS, enabling organizations to harness the power of technology for improved efficiency and data management.
His extensive experience in areas such as Technology & Site Transfer, Vendor Development, Remediation & Risk Management, Policy Formulation & Implementations, and Process Validation further solidifies his position as a subject matter expert in regulated industries.
In summary, he is a highly certified and experienced trainer with over two decades of dedicated expertise in quality assurance, compliance, and technology integration in regulated industries. His commitment to empowering individuals and organizations with the knowledge and skills necessary for success positions him as an invaluable resource in industries where quality, compliance, and technology are critical.
Pari is a Corporate Trainer For
ISO 9001:2015 Lead Auditor
Training Since:October, 2022
Lean Six Sigma Black Belt
Training Since:June, 2023
Quality Management Systems
Training Since:May, 2020
Regulatory Compliances
Training Since:November, 2017
Vendor Development
Training Since:May, 2016
Remediation & Risk Management
Training Since:November, 2018
Policy Formulation & Implementations
Training Since:November, 2019
ESG
Training Since:September, 2023
Work Experience
Principle Consultant
Pharmaceutical · March, 2022 - present
Roles & Responsibilities
- Conducted third-party audits and due diligence assessments to evaluate compliance with regulatory requirements and industry best practices
- Led GMP audits to ensure adherence to Good Manufacturing Practices and regulatory guidelines
- Prepared the organization for inspections by conducting thorough assessments, document reviews, and facility inspections
- Verified the correct execution of FDA remediation plans, ensuring that identified compliance issues were addressed effectively
- Performed Computer System Validation for various software systems used in laboratory and production environments, such as SAP, ERP, LIMS, e-QMS, Empower-3, Chromelon 7.3, Lab Solution, BMS, and other relevant software
- Conducted data integrity risk assessments (DIRA) and assessments for Nitrosamine and Elemental Impurity risks, implementing appropriate measures to ensure compliance
- Facilitated workshops on Data Integrity, Human Error, and other GMP topics to enhance knowledge and promote best practices among staff members
- Streamlined QC and production processes to simplify workflows, improve productivity, and achieve SLA (Service Level Agreement) and RFT (Right First Time) improvement goals
- Drove Process Excellence initiatives and implemented improvements to enhance overall equipment efficiency (OEE) in manufacturing processes
General Manager - Quality Control
Pharmaceutical · January, 2020 - February, 2022
Roles & Responsibilities
- Spearheaded the introduction of automation solutions within the QC and QA departments, resulting in substantial improvements in operational efficiency and a notable increase in OEE
- Oversaw the successful transition to a paperless QC system, leveraging E-LIMS, instrument interfaces, and electronic logbooks to streamline processes and reduce paper-based workflows
- Assumed a pivotal role in reviewing and approving validation protocols, quality policies, and procedures, ensuring strict adherence to regulatory mandates
- Took a proactive approach to managing vendor qualification processes and commercial lab qualifications, guaranteeing the establishment and maintenance of effective and dependable partnerships
- Guided the migration of IT systems to upgraded versions, leading to notable enhancements in operational efficiency and the seamless execution of data integrity programs
- Formulated and put into practice advanced investigative methodologies, fostering a culture of continuous improvement and identifying valuable process optimization opportunities
General Manager - Quality
Pharmaceutical · March, 2015 - January, 2020
Roles & Responsibilities
- Established new cGMP quality control lab and microbiology lab, completed USFDA filing as per regulations
- Completed the entire QC/Eng/Production automation process before the deadline with equipment qualification and software validation
- Successfully handled international consultants for 1.5 years (NSF, RCA, PQE) to complete the remediation process
- Received Employee Retention Award from AKORN, 3 increments for good performance
General Manager - Quality
Pharmaceutical · April, 2014 - March, 2015
Roles & Responsibilities
- Responsible for overseeing all Quality Control laboratory activities, ensuring efficient and compliant operations
- Established Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), and other
- Procedures to meet current regulatory requirements, ensuring adherence to quality standards
- Implemented a robust Environmental Monitoring and Process Qualification (EMPQ) program to ensure the sterile assurance of the plant and maintain regulatory compliance
- Managed the capital and operational expenses of the Quality Control department, optimizing resource allocation and budget management
- Fostered team building within the QC team, promoting collaboration and a positive work culture
Manager – Corporate Quality (Audit & Compliance)
Pharmaceutical · May, 2011 - April, 2014
Roles & Responsibilities
- Conducted surprise rounds at all sites, encompassing QA/QC, Egg, and Warehouse areas, and ensured timely follow-up on Corrective and Preventive Actions (CAPA) with effectiveness checks
- Prioritized training and people development initiatives to enhance the skills and capabilities of the team
- Implemented the qualification of all instruments and validation of software applications, ensuring compliance with regulatory requirements
- Reviewed and approved Master Formula Records (MFR), Batch Manufacturing Records (BMR), and validation documents to guarantee adherence to quality standards
- Harmonized SOPs and QA/QC procedures across the five plants, ensuring consistent regulatory compliance
- Conducted software validation of all the production, engineering QC, and microbiology software as per GAMP-5 and EU Annex 11. Additionally, reviewed and approved all cleaning validation, equipment qualification, and analytical method validation protocols and reports
Sr. Research Associate – II (Sr. Group Leader)
Research and Development · April, 2006 - May, 2011
Roles & Responsibilities
- Directed and managed the Audit and Compliance operations for five sites, which included injectable facilities. Oversaw the development of corporate assurance policies and centralized Standard Operating Procedures (SOPs) to ensure uniformity and compliance across all sites
- Conducted surprise rounds at all sites, covering QA/QC, Egg, and Warehouse areas. Ensured comprehensive inspections and timely follow-up on Corrective and Preventive Actions (CAPA) while conducting effectiveness checks to improve overall operational compliance
- Prioritized training and development initiatives for the team to enhance their skills and capabilities. Implemented programs aimed at improving the knowledge and performance of team members
- Oversaw the implementation of instrument qualification and software application validation processes to ensure compliance with regulatory requirements. Maintained accurate records of these activities to demonstrate adherence to industry standards
- Conducted thorough reviews and approvals of critical documents, including Master Formula Records (MFR), Batch Manufacturing Records (BMR), and validation documents. Ensured that all documents adhered to stringent quality standards and regulatory guidelines
- Worked to harmonize Standard Operating Procedures (SOPs) and Quality Assurance/Quality Control (QA/QC) procedures across the five plants. Ensured all sites followed consistent regulatory compliance, promoting efficiency and adherence to industry standards
Skills
- Quality Management System
- Pharmaceutical
- Biotechnology
- Regulatory Audit
- Computer System Validation
- Data Integrity
- Operational Exellance
- Green Field Project
- LIMS
- Microsoft Office
- SDLC
Education
Sri Satya Sai University of Technical and Medical Science
Chemistry
2016-2022
Sikkim Manipal University
HRM
2009-2011
Bharathidasan
Industrial Chemistry
1993-1995
Projects
Operational Excellence
July 2022 - February 2023
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