Sunit

Quality Risk Management Trainer in Mumbai

Good Documentation Practices and Data Integrity
Document Lifecycle Management
Technical Documentation
Quality Risk Management
Quality Management System
Management Escalation Process
QA Oversight
Quality Metrics
Product Release
Handling of Deviations

Location: Mumbai, India
Trainer Since: April, 2001

Trainer profile

Quality Risk Management Trainer in Mumbai

About Sunit

Sunit is a distinguished and revered trainer in the pharmaceutical industry with an impressive career spanning over two decades. Since 2001, he has profoundly impacted the professionals he works with through training and qualification programs. Sunit's vast expertise includes pharmaceutical development, product transfer, manufacturing, projects, quality, compliance (QMS), resource optimization, and productivity improvements.

With a keen eye on industry trends and expectations, Sunit equips professionals with the knowledge and skills required to excel in the ever-changing healthcare landscape. His contributions have impacted the future of pharmaceutical development, preparing individuals to thrive in this dynamic field.

As a Good Manufacturing Practices (GMP) Trainer and Quality Assurance Trainer, Sunit plays a pivotal role in shaping the future of professionals and organizations within the pharmaceutical sector, making him an invaluable asset to the field. From real-life examples, challenges, and solutions, Sunit imparts invaluable operational wisdom, creating a transformative learning experience for his trainees. A strong focus on customer-centricity drives him, and he has a passion for team management, successfully instilling quality systems, and fostering a culture of continuous improvement in various organizations worldwide.

Sunit is a Corporate Trainer For

Good Documentation Practices and Data Integrity

Training Since:April, 2001

Document Lifecycle Management

Training Since:April, 2001

Technical Documentation

Training Since:April, 2001

Quality Risk Management

Training Since:April, 2001

Quality Management System

Training Since:April, 2001

Management Escalation Process

Training Since:April, 2001

QA Oversight

Training Since:April, 2001

Quality Metrics

Training Since:April, 2001

Product Release

Training Since:April, 2001

Handling of Deviations

Training Since:April, 2001

Work Experience

Principal Consultant
Pharmaceutical · November, 2018 - present
Roles & Responsibilities
- Resolving pharmaceutical industry deficiencies and providing expertise in Quality Management Systems, training, and quality metrics
- Conducting GMP and CSV gap assessments, compliance audits, and due diligence audits
- Leading 'Inspection Ready' programs & providing remediation services for non-compliance issues
- Offering GCP-related services, documentation support, and lean process implementation
- Providing services in development, validation, and qualification for pharmaceutical industries
Quality Head
Pharmaceutical · October, 2016 - October, 2018
Roles & Responsibilities
- Led site remediation and compliance program to ensure adherence to regulatory standards
- Oversaw Quality Management (QA & QC) and implemented effective systems to maintain high-quality standards
- Provided support in manufacturing and compliance issues, addressing and resolving them promptly
- Liaised with health authorities and qualified persons to ensure regulatory compliance and successful inspections
- Drove quality cultural change and implemented data integrity initiatives across the organization
- Strategically planned and reviewed project status, optimizing the budget allocation and efficiently resolving partner issues
Regional Quality Head
Pharmaceutical · April, 2001 - September, 2016
Roles & Responsibilities
- Responsible for overseeing and ensuring adherence to quality standards and regulations across various locations within the region.
- Conducting comprehensive quality audits and inspections of processes, products, and facilities, identifying areas for improvement, and implementing corrective actions.
- Involved in collaborating with cross-functional teams to establish quality improvement initiatives, sharing best practices, and facilitating knowledge exchange among teams.
- Analyzing historical quality data and performance metrics to track trends, identify root causes of issues, and develop strategies for enhancing overall product and process quality.
- Provided training and guidance to teams on quality assurance methodologies, fostering a culture of quality consciousness and continuous improvement.
Analytical Development Executive
Pharmaceutical · September, 2000 - March, 2001
Roles & Responsibilities
- Developed and validated analytical methods to ensure accurate and reliable data
- Led product transfer (Technology Transfer) initiatives, ensuring seamless transitions between development and production
- Executed process and cleaning validation studies to maintain quality and compliance with industry standards
- Ensured regulatory compliance and maintained proper documentation for analytical processes
- Managed analytical instruments and equipment, ensuring their calibration and proper functioning
- Collaborated with cross-functional teams to achieve project success and deliver high-quality products
Analytical Development Chemist
Pharmaceutical · May, 2000 - August, 2000
Roles & Responsibilities
- Developed and validated analytical methods to ensure precise and reliable results
- Qualified and calibrated analytical instruments to maintain accurate measurements
- Conducted routine analytical testing on various samples to assess product quality and compliance
- Analyzed and interpreted data, ensuring its accuracy and relevance for decision-making
- Supported quality control activities and effectively troubleshoot any analytical issues that arose
- Collaborated with cross-functional teams to achieve project goals and maintained compliance with industry regulations and standard
Analytical Development Chemist
Pharmaceutical · April, 1999 - April, 2000
Roles & Responsibilities
- Developed and validated analytical methods, ensuring accuracy and reliability in the testing process
- Performed sampling and testing using established procedures to assess product quality and compliance
- Managed instrument calibration and qualification to maintain precise and consistent measurements
- Analyzed and interpreted analytical data, providing valuable insights for decision-making
- Maintained detailed documentation and reporting of analytical results for future reference and audits
- Contributed to regulatory submissions as required, supporting the compliance and approval processes