Deep Upadhyay Email and Phone Number
Deep Upadhyay personal email
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An enterprising leader with a proven career in crafting and executing strategies, I specialize in providing oversight and direction to ensure sustainable growth through inspiring leadership, rich experience, and innovation excellence. My target is to express my potential in leadership roles across Quality Assurance & Control, Regulatory Audits & Compliances, Operational Excellence, and Strategic Evolution within Pharma and associated industries.I bring visionary skills to achieving business growth objectives, optimizing the entire value chain, developing AOPs, and ensuring the attainment of targeted top and bottom-line results. My expertise includes turning around businesses by proactively analyzing performance, identifying bottlenecks, and maximizing competitive strength for long-term success.In Quality Management System, I have faced multiple audits from regulatory bodies like USFDA, MHRA, EUGMP, EDQM, PMDA, TGA, KFDA, ANVISA, ANMAT, COFEPRIS, WHO, ISO 9001:2015, ISO 17025 (NABL), and have excelled in recommending and implementing corrective actions while ensuring sustainable compliance and continuous improvement. I am adept at analyzing problems, driving root cause analysis, and implementing improved methods and procedures to achieve product excellence at optimized costs. As an ambassador of change, I have successfully identified process flows, enhanced systems, and augmented process efficiencies through improvement projects, reducing risks and optimizing operations. I am skilled in performing cGMP & GLP gap assessments, preparing for regulatory inspections, and responding effectively to inspectional observations.My proficiency extends to deploying various methodologies for analyzing production processes, recommending modifications to minimize escalations and rejections, and achieving operational efficiencies and cost control.I have a track record of driving process improvement through methodologies like Lean, 5S Concepts, Fish-Bone Diagram, TQM, and Industry 4.0, leading to productivity and quality improvements. Additionally, I have expertise in strategic planning, business model restructuring, cost control, and effective management of cultural diversity.As a people manager, I excel in recruiting, leading, training, motivating, and monitoring high-performing multicultural teams, ensuring high morale, low attrition, and delivering business value within deadlines.
Pi Industries Ltd
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Head Quality (Sr. Vp)Pi Industries Ltd May 2020 - PresentGurgaon, Haryana, In• Demonstrated functional leadership across Quality, Compliance, Regulatory Audits, Sustainability, and ESG processes.• Conducted technical & GMP assessments (due diligence) for acquisitions and mergers in the pharmaceutical sector, encompassing shortlisting, GMP evaluation, due diligence & decision-making processes, resulted into successful acquisitions.• Successfully collaborated as core leader in defining the organizational Compass and a certified change agent and trainer to lead the transformational change.• Implemented strategies to safeguard Customer Property & IP while enhancing overall customer experience in CDMO business model• Led over 100 customer audits & visits spanning regions like the Japan, EU and Brazil.• Certified change agent and trainer for organisational change. • Received two Golden Peacock national quality awards for excellence in Quality. • Digitalisation: Led the integration / implementation of advanced technologies such as: Laboratory Information Mgmt Systems (LIMS), project management tool, Document Management system (DMS). • Additionally, orchestrated the development of a customer portal to streamline interactions & implemented robust document management systems. These initiatives will revolutionize operational efficiency, improved customer experience & ensured data accuracy, significantly enhancing organizational effectiveness.• Led Quality, Health, Safety & Environment (QHSE) audit teams with a strong focus on ESG Governance & compliance.• Established & optimized operational processes to enhance customer satisfaction. Implemented CSAT and NPS surveys to gauge customer sentiment. Achieved an impressive CSAT score of 86%, reflecting the success of customer-centric initiatives.• Successfully planned & achieved organizational goals pertaining to "ESG governance & Responsible Care."• Spearheaded continual improvement initiatives through the Quality Circles, LEAN, TQM-PDCA approach and effective Review & Governance Mechanisms.
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Sr. Gm & Site Head (Cluster Quality)- 2 SitesGlenmark Pharmaceuticals Apr 2013 - Apr 2020Mumbai, Maharashtra, In• Successfully led the organization as head cluster quality for entire value chain in quality from Technology transfer, validations, Regulatory filings, successful regulatory audits, product launches, continued commercial supplies and sustained GMP & Regulatory compliance for API’s, various formulations like (OSD including Oncology products, Inhalers (MDI & DPI), Topical Foams. • Successful commissioning and qualification of new facilities and on-time readiness for product manufacturing and launches.• Demonstrated expertise in regulatory compliance by successfully leading 10 regulatory inspections (USFDA, Various EU regulatory agencies, ANVISA, ANMAT, KFDA) without receiving any adverse inspection reports• Successfully led over 100 international customer audits spanning regions like the USA, EU, and Japan.• Successfully implemented various digitalization initiatives like QMS, Laboratory compliance systems, document management system.• Consistently achieved 100% of organizational goals during 7+ years tenure.• Spearheaded cultural transformation & quality culture building initiatives, ensuring data accuracy & integrity.• Knowledge management and GMP trainings at site to drive the business needs.• Computer system validation and compliance as per the requirement of 21 CFR part 11 and other CSV requirements ensuring data accuracy and data integrity.• Collaborated with esteemed external partners & consultants on quality, compliance & training initiatives.• Exhibited exemplary leadership qualities by fostering team building, facilitating people development, and ensuring effective governance, achieving a Team Engagement score surpassing 90%. -
Associate Director Qa -Head Qa- 2 SitesTeva Api India Limited Dec 2011 - Mar 2013Tel Aviv, Il• Successful quality and compliance ensuring and led various regulatory inspection (USFDA and KFDA). • Ensured punctual commercial deliveries & successful new product launches while upholding stringent quality, compliance & safety standards to all international customers.• Harmonized change management system across Teva’s 17 manufacturing sites across the globe.• Implemented digital tool for quality management systems- Track-wise and LIMS.Implemented proactive strategies for Quality Risk Assessment for prevention of Contamination Prevention, and various other product quality assurance aspects. -
Site Quality HeadJubilant Life Science Limited Apr 2006 - Dec 2011Noida, Uttar Pradesh, In• Worked as Senior Manager Corporate Quality for Initial 4.5 Year and Then as Site Quality Head for Bharuch Manufacturing Site.• Established corporate quality function at developmental QA (R&D QA) at Jubilant. • Commissioned and Qualified two greenfield manufacturing facilities - Finished pharmaceutical dosage forms at Roorkee and API at Bharuch.• Harmonized quality systems across finished formulation and API manufacturing sites. • Set up processes for manufacturing and technology transfer processes to external manufacturing sites.• Established and led centralized Vendor qualification and onboarding process for entire organization. • Developed and Established Quality Systems, and ensured harmonization & compliance.• Ensured robust Computer System Validation & Compliance with standards such as GAMP 5, 21 CFR part 11, and EU Annex-11 ensuring data integrity and assurance for the first time at Jubilant.• Participated and guided for various regulatory audits at manufacturing sites.• Represented as certified proxy auditor on behalf of European Qualified Person (QP) for various CDMO & Vendor audits in India.• Conducted comprehensive audits & ensured GMP compliance of both internal manufacturing sites & strategic vendors. • Monitored & controlled external manufacturing partners & suppliers, conducting over 100 GMP audits globally.• Oversaw regulatory submissions, including ANDA’s, MA’s, DMF’s, CTD’s filings, and managed regulatory query responses, approvals & commercial launches.• Guided regulatory audit response writing, identified gaps, developed CAPA plans & ensured timely implementation & effectiveness monitoring for inspection closure. -
Quality Assurance ManagerLupin Limited Oct 2002 - Apr 2006• Worked as Group Leader QA at Mandideep (OSD & Sterile) and then as Manager QA for Tarapur (API-Fermentation based) Manufacturing site.• Contributed as Group leader for Mandideep facility for finished dosage forms: OSD – Tablets, Capsules & Dry syrup and Sterile products (powder for Injection).• Contributed as group leader for longest and successful USFDA audit of 17 days for OSD, Sterile and API products. • Digitalization: Worked as core member for SAP implementation at Mandideep location.• Coordinated & guided stakeholders on processes and quality excellence aspects, including R&D, supply chain, operations, engineering, and projects.• Actively participated various regulatory audits (USFDA, EDQM, WHO) and many international customer audits. • Led as head QA for Fermentation based API products at Tarapur location.• Successfully led the USFDA inspection without any observation for fermentation-based API’s.
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Qa Officer-Validation And DocumentationUnichem Laboratories Limited Jan 2001 - Oct 2002• Worked as core team member of manufacturing plant and Laboratory modernization team. • Renovated and Qualified Quality control laboratory as per the GMP norms. • Implemented Good Laboratory practices, and responsible for daily and periodic calibration of laboratory instruments. • Coordination and Execution of AMCs for Laboratory instruments.• Prepared and implemented various process control procedures and specifications for the implementation at the shop floor to ensure adequate process control measures.• In process quality control mentoring for various products OSD, Liquid Orals, and Parenteral products.• Control Sample Management.
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Jr. Officer QaIpca Laboratories Limited Oct 1999 - Dec 2000Mumbai, Maharashtra, In• Document management and Control across all manufacturing blocks.• Review of Batch production and analytical records before product release.• Performing Cleaning and process Validation for various products. Performing Analytical method validation for cleaning samples. • Shopfloor monitoring as QA Inspector to ensure GMP compliance and In-process controls, line clearance etc.• Participated and demonstrated various quality processes to USFDA inspectors and Customer Auditors during the audits. -
Quality Control ChemistDabur India Limited Feb 1996 - Oct 1999Ghaziabad, Uttar Pradesh, In• Sampling and quality control analysis of raw and packing materials and Finished products (OSD, FMCG and Nutraceutical products).• Instruments Handled: UV, FTIR, Flame photometer, Auto titrator, KF and HPLC • Line clearance and In-process Quality control monitoring.• Worked as approved analytical Chemist from FDA Rajasthan for Chemical and Instrumental analysis.• Preparation of Specifications, Test Methods and SOP’s• British Health Products Limited is subsidiary and wholly owned company of Dabur India Limited.
Deep Upadhyay Skills
Deep Upadhyay Education Details
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Icmind Instutute Of ManagementManagement Studies With Specialisation In Quality Management -
Kumaun UniversityElementary Education And Teaching
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Kumaun UniversityOrganic Chemistry
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Xlri JamshedpurManagement
Frequently Asked Questions about Deep Upadhyay
What company does Deep Upadhyay work for?
Deep Upadhyay works for Pi Industries Ltd
What is Deep Upadhyay's role at the current company?
Deep Upadhyay's current role is Head Quality @ PI Industries Ltd | Quality Management | Lean Six Sigma Black Belt | Certified ESG Impact Leader | Sustainability.
What is Deep Upadhyay's email address?
Deep Upadhyay's email address is up****@****ail.com
What schools did Deep Upadhyay attend?
Deep Upadhyay attended Icmind Instutute Of Management, Kumaun University, Kumaun University, Xlri Jamshedpur.
What skills is Deep Upadhyay known for?
Deep Upadhyay has skills like Equipment Qualification, Cleaning Validation, V&v, Gmp, Sop, Validation, Glp, Technology Transfer, Capa, Regulatory Affairs, Fda, Pharmaceutical Industry.
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