Ajai Kumar Benjamin

Quality & Compliance | Lead Auditor - ISO9001 & FSSC 22000 | Pharmaceutical | FMCG | Consumer Healthcare

Accomplished and customer-centric leadership professional, focused on quality assurance and commercial operation management with over 18 years of
proven excellence in pharmaceutical and consumer healthcare industries. With a strong base in microbiology, and over 10 years of people management,
demonstrated success in designing, developing, and implementing quality strategies, cGMP, and regulatory compliance. Committed to assessing product
quality for achieving 100% customer satisfaction. Passionate about being solution-oriented for complicated issues, helping organizations to identify pain
areas, and providing strategic, and cost-effective solutions. A certified lead auditor, significantly skilled in auditing, coordination with regulatory bodies, client
and stakeholders management. Adept in budget management, continuous improvements, and process excellence with lean management, mentoring, and
coaching of employees. Exploring to pursue a career in the upper echelons of an esteemed organization, that calls for extremely high levels of leadership
qualities, technical abilities, and expertise.

ajaikumarqc@gmail.com +971 54 74 666 34 / +91 9000 894028 Dubai - UAE / Hyderabad - INDIA

WORK EXPERIENCE SKILLS

Consultant - Quality, GMP & Organizational Excellence Quality Assurance & Control
Freelance
01/2023 - Present, Dubai, United Arab Emirates
Quality audits Training
Achievements/Tasks
Lean Six Sigma QMS
SME advisory: Advise clients and entrepreneurs globally on quality management systems, business
continuity planning management, market analysis, and penetration strategies. Lead Auditor ISO 9001:2015
Sourcing projects: Support organizations for sourcing suppliers for APIs, Packing materials,
Equipment, Logistics, and Supply chain partners. Lead Auditor FSSC22000
Commercial Operation: Direct the documentation process for regulatory approval, business
continuity planning management, advice on potential supplier sourcing, and surveillance audits. Deviations PICs / ICH

QMS documentation: Being a certified Lead Auditor, overseeing preparation and review of Quality Change Control LMS
manual, Site master file, SOPs, and QMS for accreditation of facility for ISO9001, ISO17025,
FSSC22000, and ISO13485. Continuous Improvement

Director of Quality, Global External Manufacturing Sourcing & CMO CAPA Risk management
Regulations
RCA GMP/GDP/GLP
CMS Bridging DMCC
07/2020 - 12/2022, Dubai, United Arab Emirates Vendor management
A business unit of China Medical System Holdings Ltd., a Hong Kong-based pharmaceutical company principally
engaged in the manufacturing, marketing, promotion, and sales of pharmaceutical products globally.
Resource planning
Achievements/Tasks
Spearhead the commercial quality management and contract manufacturing operations (CMO) of Supply Chain & Logistics
Medical devices, Cardiovascular and Dermatological projects across Europe, and ROW markets.
Contributed strategic support for commercial projects, facility acquisition, sourcing & qualification of Microbiology
potential manufacturers, resource planning, monitoring trends of global sales & distribution.
Molecular Biology
Coordinated with CMOs to drive QMS, documentation process review/approval, customer
complaints, manufacturing process, addressing opportunities of improvements.
Promoted effective quality principles at Commercial Affiliates while minimizing cost and potential
disruptions to business and Coordinate activities between CMOs, and distribution centers as
necessary to ensure policy requirements are met with respect to field actions.
CERTIFICATES
Advised management of compliance status and risk and Oversee fulfillment of GDP compliance with
Lead Auditor ISO 9001:2015, CQA-
global supply chain operation for APIs and finished goods in Europe and ROW markets (North
IRCA UK
America, Australia, China, Pakistan, South Korea, and Turkey).
Achieved 12% cost-saving in total logistics expenses by effective alignment of manufacturing Lead Auditor FSSC 22000, CQA-IRCA
planning with logistics operations. UK
Established the new supply chain network from Europe to the UK on-behalf of Brexit regulations.
Lean Six Sigma Black Belt (LSSBB),
Appreciated for assuring “Zero Stock-out” occurrence in market supply in Europe and the ROW Henry Harvin India
market.
Recognized for 23% cost reduction in acquiring a manufacturing facility in Europe from the projected Project Management Professional,
quote. PMI - USA
Appreciated for identifying risk, and pain areas in manufacturing and market supply and
Logistics and Supply Chain
implementing corrective measures.
Management, AIBM - USA

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 WORK EXPERIENCE EDUCATION
Site Quality Head M.Sc. Microbiology 2003
Gulf Center Cosmetics Manufacturing LLC. Madurai Kamaraj University -
01/2018 - 02/2020, Dubai, United Arab Emirates INDIA
MOH-UAE approved manufacturing facility for medical devices of Glaxo SmithKline Consumer Healthcare
Achievements/Tasks
Provided leadership and quality oversight for consumer healthcare manufacturing facility, QA/QC
functions, packaging, distribution, product commercialization and release of oral care and personal
care (FMCG) ranges for domestic & GCC.
LANGUAGES
Spearheaded end-to-end inspection readiness program, response to observation, implementation of English
CAPAs, fulfilling the compliance of ISO13485 (medical device), ISO9001, ISO22716 and ISO17025 Full Professional Proficiency
requirements.
Overseen specifications of RM, SFG, FG, and Packing materials, review/approval of SOPs, STPs, Hindi
ROAs, MSDS, COAs of QC assignments, on-time batch release, and regulations. Native or Bilingual Proficiency

Improved overall QMS performance, monitoring Stability studies, Data Integrity & ALCOA compliance,
Vendor management, Investigations, HALAL, HACCP, Process & Cleaning validation, and equipment
lifecycle management.
Strategized periodical evaluation of analytical practices, trends, challenges, risk assessment
COMPETENCIES
programs, and mitigation plans.
Secured MOH-UAE approval, acquired manufacturing license for medical devices in GSK’s UAE Leadership Solution-driven
facility, and achieved commercial launching of new medical device variants (14 SKUs) in UAE.
Optimized the key functions between stakeholders to ensure operations are keeping up with TAT Customer-focused
and meeting the customer's expectations.
Critical thinking
Recognized for obtaining a 4-star rating of the site by GSK Corporate for achieving compliance with
regulatory & quality standards.
Learn from failures
Achieved 100% of customer retention by enhancing customer satisfaction levels by optimizing QA
and manufacturing process. Conflict management

Manager - Quality Assurance and Quality Control Commercial acumen

Dr. Reddy's Laboratories Ltd, (Biologicals).
07/2012 - 12/2017, Hyderabad, India
Achievements/Tasks
2012-2014, as a Manager-Quality Control (Microbiology), Led the product testing team in WORK HISTORY
conducting testing and timely release of biosimilars (injectables-Rituximab, Filgrastim, Darbepoetin,
and other MABs) at DS, FDS, FG stages & packaging materials.
Swiss Garnier Life Sciences, INDIA
Ensured 100% of batches met the Turnaround time (TAT) for commercial batch testing/release and > (2011 - 2012)
99% of batches met the TAT for stability testing. QC Manager (Microbiology & Probiotics facility)
Instrumental on investigations, deviations, change, CAPA, OOS/OOL/OOT and ensured timely closure
of reports. Orchid Pharma, INDIA (2010 - 2011)
Research Associate (Molecular Biology: beta-
Steered efforts in enhancing quality systems deployment within the department, developed and lactam research facility)
executed continuous improvement.
Empowered and mentored staff, ensured effective utilization of all quality management systems by Evolva group, INDIA / DENMARK
laboratory personnel, maintained the compliance metrics, and reported to the top management. (2007 - 2010)
Project Manager & Scientist (Genetic Chemistry
2014-2017, as a Manager - Quality Assurance, supported overall QMS health and governance of & Drug Discovery Projects)
compliance. on-time closure of deviations/Change Controls/CAPAs/ for > 95%.
Appreciated for the timely closure of > 95% of reports (deviations/Change controls/CAPAs/OOS ). Biogenomics Ltd, INDIA (2006 -
2006)
Achieved a significant cost-reduction of QC analysis cost by 21% through implementing simplified Microbiologist (R&D facility of Insulin, Human
procedures; Optimized the elimination of non‐value‐added sampling & minimized the cost of Growth Hormone and Filgrastim)
analysis up to 31% at the In‐process stages.
Appreciated for implementing efficient CAPAs for repeated BET failures, caused by The MS University of Baroda, INDIA
human/laboratory error deviations. (2004 - 2006)
Junior Research Fellow at Genome Research
Supported assuring "Zero critical observations" from regulatory and customer inspections by QP UK, Center for Riceplant and pathogenic fungi
Lachman US, MERCK SERONO, MHRA UK, INVIMA Colombia, and ANVISA Brazil. Magnaporthe grisea.

AFFILIATIONS MISCELLANEOUS

Member of ASQ US Member of PMI US Open for relocation

Comfortable with business traveling

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