Dr. Ajay Babu Pazhayattil Email and Phone Number
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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
Cgmp World
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Management ConsultantCgmp World May 2021 - Present𝐌𝐚𝐣𝐨𝐫 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. -
Vice President, Quality, Scientific And Regulatory AffairsCapcium Inc. Feb 2022 - Jan 2023Pointe-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. -
Management ConsultantEliquent Life Sciences Jan 2019 - Feb 2022𝐌𝐚𝐣𝐨𝐫 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. -
Director Of QualityEurofins Cdmo 2018 - 2019Fontenilles, 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. -
Associate Director Of Technical Operations, Process ValidationApotex Inc. 2012 - 2018Toronto, 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. -
Senior Quality Assurance ManagerAni Pharmaceuticals, Inc. 2008 - 2012Princeton, New Jersey, Us -
Quality Assurance ManagerVita Health Products Inc. 2006 - 2008Winnipeg, Mb, Ca -
Quality Assurance AssociateThermo Fisher Scientific 2006 - 2006Waltham, Ma, Us -
Regulatory Affairs Specialist, Technical AffairsMarcan Pharmaceuticals Inc. 2004 - 2006Ottawa, Ontario, Ca -
Validation OfficerIntas Pharmaceuticals 2001 - 2003Ahmedabad, Gujarat, In
Dr. Ajay Babu Pazhayattil Skills
Dr. Ajay Babu Pazhayattil Education Details
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California Southern UniversityManagement And Operations -
Rajiv Gandhi University Of Health SciencesPharmaceutical Chemistry -
Mangalore UniversityPharmacy
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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