Ajai Dubai United Arab Emirates

Ajai

Quality Management Systems Trainer in Dubai
Location
Dubai, United Arab Emirates
Trainer Since
June, 2014
Quality Management Systems
Location
Dubai, United Arab Emirates
Trainer Since
June, 2014
Quality Management Systems

Quality Management Systems Trainer in Dubai

About Ajai

Ajai is a seasoned Quality Management Systems trainer with over a decade of experience in the field. With a genuine dedication to excellence, Ajai has carved a niche for himself as a dynamic professional in the Biopharmaceutical and Consumer Healthcare industries. His expertise extends far beyond conventional boundaries, encompassing the intricate realms of Research and Development in Drug Discovery genetics. Ajai's illustrious career is underscored by a robust track record of conceiving, refining, and executing quality strategies, culminating in regulatory compliance and marketplace triumph.

As a certified lead Auditor of ISO9001 and FSSC22000, Ajai brings a wealth of expertise in quality auditing and compliance management. Renowned for his innate problem-solving understanding, he can delve deep into issues and engineer innovative, cost-effective solutions. However, Ajai's proficiency transcends mere technical prowess; with over a decade of team leadership experience, he has honed his skills in motivation and capacity-building, emerging as a beacon of inspiration for his peers. An ardent advocate for mentorship and coaching, Ajai takes immense pride in nurturing the talents of others and fostering an environment of continuous learning and professional growth.

Ajai is a Corporate Trainer For

Quality Management Systems

Training Since:
June, 2014

Work Experience

Corporate Trainer

Pharmaceutical:
February, 2014 - present

Roles & Responsibilities

  • Create and implement training modules tailored to clients' needs, focusing on quality management principles, training frameworks, and preparation techniques. Ensure these programs align with industry standards and client objectives
  • Lead engaging workshops and seminars to educate employees and stakeholders on quality management practices, training methodologies, and compliance requirements. Foster an interactive learning environment to maximize participant engagement and knowledge retention
  • Offer expertise in developing and maintaining internal documentation systems for compliance verification and improvement purposes. Assist clients in establishing robust documentation practices to streamline processes and ensure regulatory compliance
  • Consult with companies and entrepreneurs to develop effective business continuity plans that mitigate risks and ensure operational resilience. Provide insights and recommendations on contingency measures, crisis management strategies, and disaster recovery protocols.
  • Collaborate with clients to identify potential suppliers and manufacturers that meet their quality standards and business requirements. Conduct thorough assessments and evaluations to ensure supplier reliability, product quality, and regulatory compliance
  • Act as a reliable resource and advisor to clients, offering valuable insights, best practices, and recommendations in quality management, training methodologies, and compliance strategies. Utilize domain expertise to empower clients in making informed decisions and achieving their business objectives

Director Quality and Global External Manufacturing

Pharmaceutical:
July, 2020 - December, 2022

Roles & Responsibilities

  • Developed and implemented comprehensive training programs for Good Distribution Practices, stakeholder management, customer relationship improvement, and sales monitoring at a leading global pharmaceutical company
  • Oversaw sourcing projects, serving as subject matter expert (SME) for sourcing vendors and service monitoring
  • Conducted regular feedback and improvement programs for vendors and services, ensuring alignment with quality standards and organizational objectives
  • Spearheaded initiatives to enhance customer satisfaction and stakeholder engagement through effective communication and relationship-building strategies
  • Played a pivotal role in designing and executing quality assurance protocols for global external manufacturing processes, ensuring compliance with regulatory requirements and industry standards
  • Collaborated cross-functionally with internal teams and external stakeholders to identify areas for improvement and drive continuous quality enhancement efforts throughout the supply chain

Quality and Compliance Manager

Manufacturing:
January, 2018 - February, 2020

Roles & Responsibilities

  • Led site Quality and Compliance management efforts at one of the leading contract manufacturing facilities for FMCG ranges in UAE, owned by Albatha business group
  • Provided coaching and feedback to management teams, fostering collaboration on performance improvement initiatives
  • Implemented awareness programs to enhance understanding of quality and compliance standards among staff
  • Spearheaded capacity improvement initiatives to optimize operational efficiency and meet regulatory requirements
  • Developed training priorities for the year, aligning training themes with business objectives
  • Designed training content tailored to organizational and functional needs, ensuring effective and high-quality employee delivery

Manager - QA and QC

Pharmaceutical:
July, 2012 - December, 2017

Roles & Responsibilities

  • Strategic direction to a team of 18 members in conducting testing and timely release of biosimilars at DS, FDS, FG stages, & Packing Materials
  • Instrumental on investigations, deviations, change, CAPA, OOS/OOL/OOT, and ensured timely closure of reports
  • Steered efforts to enhance the quality systems' deployment within the department and executed continuous improvement
  • Implementing simplified procedures achieved a significant cost reduction of QC analysis by 21%
  • Appreciated for the timely closure of > 95% of reports (deviations/Change controls/CAPAs/OOS)
  • Led QMS to increase customer satisfaction through high product quality and ensured cGMP compliance
  • Optimized the elimination of non-value-added sampling & minimized the cost of analysis by 31% at the In-process stages.
  • Appreciated for implementing efficient CAPAs for repeated BET failures and human/laboratory error deviations
  • Appreciated for implementing efficient CAPAs for repeated BET failures caused by human/laboratory error deviations

Project Manager & Scientist

Pharmaceutical:
June, 2007 - August, 2010

Roles & Responsibilities

  • Led projects sponsored by the Defense Threat Reduction Agency (DTRA, USA) and Army Research Organization (ARO, USA) aimed at discovering novel molecules with anti-viral and anti-cancer properties through combinatorial biosynthesis
  • Directed efforts to identify antibacterial molecules targeting Burkholderia, a potential bioweapon, through global research initiatives
  • Managed implementation of Laboratory Information Management System (LIMS) to streamline data management across R&D laboratories, enhancing efficiency and accuracy
  • I spearheaded a project as a project manager in anti-fungal (veterinary application), overseeing the successful positioning of a potent anti-fungal candidate against animal pathogenic fungi, including MDR strain Scopulariopsis
  • Orchestrated collaboration between a Contract Research Organization (CRO) and a government organization for efficacy analysis, bio-distribution, mechanism of action (MOA) studies, and animal experiments
  • Led the development of new formulations for the potent anti-fungal molecule, ensuring its suitability for veterinary applications and advancing its potential for market entry

Skills

Quality Management Systems
Risk Assessment
Lean Six Sigma
Vendor Management
GMP
Deviations
Change management
Corrective Action and Preventiva Action (CAPA)
Root Cause Analysis
Audits

Education

Madurai Kamaraj University

Microbiology:
2001-2003

Madurai Kamaraj University

Microbiology:
1998-2001

Projects

Project Orange

Pharmaceutical:
January 2021 - September 2021

Posts

Project Orange

Pharmaceutical:
January 2021 - September 2021

Courses

Quality Management Systems

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