Dr. Ajay Babu Pazhayattil

Dr. Ajay Babu Pazhayattil Email and Phone Number

Vice President | Pharmaceutical Management Consultant | Validation, Quality, Technical Operations Leader | Author | 24K+ @ cGMP World
Dr. Ajay Babu Pazhayattil's Location
Greater Toronto Area, Canada, Canada, Canada
Dr. Ajay Babu Pazhayattil's Contact Details

Dr. Ajay Babu Pazhayattil personal email

About Dr. Ajay Babu Pazhayattil

Welcome to my LinkedIn profile! I am a passionate and results-driven pharmaceutical leader focused on delivering exceptional value. With the combination of technical expertise, quality, compliance background, regulatory acumen, and a commitment to excellence, I have a proven track record of driving success and ensuring the highest standards throughout the 22+ years of my career:🗸 I have remediated several complex US FDA warning letters and 483 scenarios as an SME. 🗸 My leadership has orchestrated successful Rx launches with a 100% success rate. 🗸 My expertise in providing science-based innovative solutions for regulatory submissions to pharmaceutical process remediations has yielded positive results. 🗸 By applying robust quality systems and risk management strategies, I have reduced failure rates by an impressive 30% y/y. 🗸 I have hosted regulatory audits by the US FDA, Health Canada, and others, showcasing the company's GMP compliance excellence. 🗸 I have led over 100 pharmaceutical cGMP audits of facilities worldwide. 🗸 I am a known influencer, subject matter expert in pharmaceutical manufacturing technology, process validation, and quality/compliance. 🗸 While embracing technology innovations, I have developed the first PV lifecycle management system, the first-ever Pharma cGMP app, and implemented/enhanced QMS(TrackWise, Solabs, EtQ)/ERP(SAP) software. 🗸 I am proficient in using data-driven statistical tools such as SAS JMP, Minitab, visualization, and BI. 🗸 I have been influential in establishing applied statistics groups and creating forums, resulting in innovation and value creation (knowledge/capability). 🗸 I have authored pharmaceutical industry textbooks, guidance, and journals, solidifying my position as a respected authority.Colleagues frequently describe me as a progressive, driven, down-to-earth, approachable pharmaceutical thought leader known for delivering superior strategies, providing support to navigate difficult scenarios and offering technical/management solutions that consistently yield exceptional results. Let's connect and embark on a transformative journey together!Contact me here/email: ajpazha@gmail.com/phone: 438-526-1975.Experienced Pharmaceutical Leader | Management Consultant | Transformational Leader | Small Molecules | Biologics | Strategic Leadership | Validation SME | Regulatory Compliance | Quality Assurance | Technical Operations | Manufacturing Science & Technology | Regulatory Affairs | Pharmaceutial | Research & Development | Quality Excellence | Science-Based Decision-Making | Leader

Dr. Ajay Babu Pazhayattil's Current Company Details
cGMP World

Cgmp World

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Vice President | Pharmaceutical Management Consultant | Validation, Quality, Technical Operations Leader | Author | 24K+
Dr. Ajay Babu Pazhayattil Work Experience Details
  • Cgmp World
    Management Consultant
    Cgmp World May 2021 - Present
    𝐌𝐚𝐣𝐨𝐫 𝐈𝐧𝐣𝐞𝐜𝐭𝐚𝐛𝐥𝐞 𝐂𝐃𝐌𝐎, 𝐌𝐃, 𝐔𝐒𝐀: Aseptic Oversight Subject Matter Expert (SME) addressing FDA warning letter commitment for aseptic practices remediation and personnel behavioural improvements. The GMP facility manufactures biopharma vial and syringe products featuring RABS and isolator technologies. 𝐌𝐚𝐣𝐨𝐫 𝐂𝐃𝐌𝐎, 𝐍𝐘, 𝐔𝐒𝐀: Conceptualized a comprehensive Master Validation Plan, promoting science and data-driven decision-making to meet Advanced Therapy Medicinal Products/Cell and Gene Therapy regulatory, compliance, and quality requirements.𝐈𝐧𝐣𝐞𝐜𝐭𝐚𝐛𝐥𝐞 𝐂𝐃𝐌𝐎, 𝐓𝐍, 𝐔𝐒𝐀: Oversaw the successful establishment of Validation and Metrology groups; controlled setting up and execution of commissioning and qualification of the new vial, syringe, and bag-filling lines in conjunction with the company's renovation and expansion projects.𝐈𝐧𝐣𝐞𝐜𝐭𝐚𝐛𝐥𝐞 𝐆𝐞𝐧𝐞𝐫𝐢𝐜, 𝐇𝐲𝐝𝐞𝐫𝐚𝐛𝐚𝐝, 𝐈𝐧𝐝𝐢𝐚: Supporting development and commercialization of high-quality niche injectables for US and Canadian markets.
  • Capcium Inc.
    Vice President, Quality, Scientific And Regulatory Affairs
    Capcium Inc. Feb 2022 - Jan 2023
    Pointe-Claire, Québec, Ca
    • Appointed as the R&D and Regulatory Affairs executive leader for this Montreal-based soft gelatin capsule CDMO.• Championed various innovations in soft gelatin capsule manufacturing technology. • Maintained oversight of quality compliance.• Identified opportunities and strategies to drive organizational success.
  • Eliquent Life Sciences
    Management Consultant
    Eliquent Life Sciences Jan 2019 - Feb 2022
    𝐌𝐚𝐣𝐨𝐫 𝐈𝐧𝐣𝐞𝐜𝐭𝐚𝐛𝐥𝐞 𝐂𝐃𝐌𝐎, 𝐌𝐃, 𝐔𝐒𝐀: Directed quality compliance assurance throughout the commissioning and qualification of mRNA vaccine facility; contributed to this critical BARDA operation warp speed project to expedite US capacities for life-saving vaccines during the pandemic.𝐌𝐚𝐣𝐨𝐫 𝐆𝐞𝐧𝐞𝐫𝐢𝐜, 𝐌𝐮𝐦𝐛𝐚𝐢, 𝐈𝐧𝐝𝐢𝐚: Guided the remediation of product and process issues highlighted in a US FDA warning letter for antibiotic powder for oral suspension products, at one of the largest single-source antibiotic formulation facilities; employed a strategic approach and meticulous science-based remediation that led to resolving the trends and regulatory concerns and restoring product supply to the US.𝐌𝐚𝐣𝐨𝐫 𝐆𝐞𝐧𝐞𝐫𝐢𝐜, 𝐅𝐋, 𝐔𝐒𝐀: Supervised and directed an FDA remediation initiative focusing on the controlled substance oral formulation facilities; achieved project goals (as displayed through the successful reinspections) through QA leadership and regulatory expertise, adherence to stringent standards, and fostering operational excellence.
  • Eurofins Cdmo
    Director Of Quality
    Eurofins Cdmo 2018 - 2019
    Fontenilles, Haute-Garonne, Fr
    • Recognized as a results-driven leader and instrumental in spearheading regulatory compliance, quality assurance, and strategic development initiatives.• Provided comprehensive oversight of pharmaceutical/medicine development and manufacturing to ensure full operational compliance at all times.
  • Apotex Inc.
    Associate Director Of Technical Operations, Process Validation
    Apotex Inc. 2012 - 2018
    Toronto, Ontario, Ca
    • Oversaw activities related to impactful management, regulatory risk mitigation, validation, technical operations, and strategy in the dynamic generic pharmaceutical development, product launch, and commercial manufacturing areas.
  • Ani Pharmaceuticals, Inc.
    Senior Quality Assurance Manager
    Ani Pharmaceuticals, Inc. 2008 - 2012
    Princeton, New Jersey, Us
  • Vita Health Products Inc.
    Quality Assurance Manager
    Vita Health Products Inc. 2006 - 2008
    Winnipeg, Mb, Ca
  • Thermo Fisher Scientific
    Quality Assurance Associate
    Thermo Fisher Scientific 2006 - 2006
    Waltham, Ma, Us
  • Marcan Pharmaceuticals Inc.
    Regulatory Affairs Specialist, Technical Affairs
    Marcan Pharmaceuticals Inc. 2004 - 2006
    Ottawa, Ontario, Ca
  • Intas Pharmaceuticals
    Validation Officer
    Intas Pharmaceuticals 2001 - 2003
    Ahmedabad, Gujarat, In

Dr. Ajay Babu Pazhayattil Skills

Gmp Pharmaceutical Industry Validation Regulatory Affairs Fda Pharmaceutics Quality Assurance Quality Control U.s. Food And Drug Administration Change Control Capa Manufacturing Sop Standard Operating Procedure Quality System Gxp Corrective And Preventive Action 21 Cfr Part 11 Sterilization Life Sciences Regulatory Submissions Good Manufacturing Practice

Dr. Ajay Babu Pazhayattil Education Details

  • California Southern University
    California Southern University
    Management And Operations
  • Rajiv Gandhi University Of Health Sciences
    Rajiv Gandhi University Of Health Sciences
    Pharmaceutical Chemistry
  • Mangalore University
    Mangalore University
    Pharmacy

Frequently Asked Questions about Dr. Ajay Babu Pazhayattil

What company does Dr. Ajay Babu Pazhayattil work for?

Dr. Ajay Babu Pazhayattil works for Cgmp World

What is Dr. Ajay Babu Pazhayattil's role at the current company?

Dr. Ajay Babu Pazhayattil's current role is Vice President | Pharmaceutical Management Consultant | Validation, Quality, Technical Operations Leader | Author | 24K+.

What is Dr. Ajay Babu Pazhayattil's email address?

Dr. Ajay Babu Pazhayattil's email address is aj****@****ail.com

What is Dr. Ajay Babu Pazhayattil's direct phone number?

Dr. Ajay Babu Pazhayattil's direct phone number is +164733*****

What schools did Dr. Ajay Babu Pazhayattil attend?

Dr. Ajay Babu Pazhayattil attended California Southern University, Rajiv Gandhi University Of Health Sciences, Mangalore University.

What skills is Dr. Ajay Babu Pazhayattil known for?

Dr. Ajay Babu Pazhayattil has skills like Gmp, Pharmaceutical Industry, Validation, Regulatory Affairs, Fda, Pharmaceutics, Quality Assurance, Quality Control, U.s. Food And Drug Administration, Change Control, Capa, Manufacturing.

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