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QUALITY PROFESSIONALQUALITY PROFESSIONALProactive, performance-driven a pharmaceutical professional with 07+ years’ of progressive expertise in Quality Management System, various Quality Operations, Regulatory Compliance, Auditing, Qualification & Validation, Training, Vendor Managements, Planning & Execution of projects and problem solving approach for Pharmaceutical services, and Startup Operations. Keen understanding of business priorities, criticality, organizational goal, and a genuine team player committed to managing site operations with quality attributes & regulatory compliance. Handle various site quality projects flawlessly. Cross-functional communicator easily interfaces with high-profile staff, Regulators, vendors, and customers. Versatile, innovative, and loyal management professional able to see the “big picture” while staying on top of all the details. Recognized for consistent success in developing the processes and procedures to streamline Quality Operations and enhance revenue performance.

Areas of Expertise Quality Management System (Change Control, Deviation, Incidents, Market Complaints, Laboratory Incidents, Gap Analysis, Quality Alerts, Annual Product Review, etc) Regulatory & Compliance Operational Quality Auditing Training Risk Management Qualification & Validation Strategic Planning Project Management Systems Development Resource Management (Vendors Management) Operational Excellency

Regulatory Audit Exposure: USFDA, WHO (Geneva), MHRA, TGA (Australia), MCC (South Africa), Japan (PMDA), ANVISA, Ukraine, Uganda, Argentina, & Indian FDA etc.

PROFESSIONAL EXPERIENCEPROFESSIONAL EXPERIENCEGLAXOSMITHKLINE PHARAMACEUTICAL LTD. GLAXOSMITHKLINE PHARAMACEUTICAL LTD. Nov 2014 – PresentNov 2014 – Present(GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies)Assistant Manager- Quality & Regulatory Compliance:Assistant Manager- Quality & Regulatory Compliance: Responsible for co-ordination with Tender Business Team, local FDA, Regional / Global

Quality function, Global production system, Manufacturing departments / Packing departments, Engineering departments, Warehouse departments and other support functions for quality & regulatory compliance.

Plan, participates, manage & track various site projects to meet in order to keep abreast ongoing organizational activities adherence with company policies and procedures related to cGMP, SOP’S, ICH Q10 & various regulatory authorities norms & identifying and addressing any gaps related to projects for product quality and GMP compliance.

Handling of the Change Controls, Deviation, Incidence / Failures, Laboratories incidents, OOS, CAPA managements, Customer Complaints, Quality Alerts & Various Non Conformances of site and ensure investigation has been carried out, potential root cause analyzed through RCA and respective Corrective and Preventive actions are in place and effectively monitored.

Monitoring & tracking of Global Quality Management System (QMS) and execute the GAP analysis activities as per the plan. Review & tracking of gap analysis and recommended actions of QMS documents at site.

Expert in Quality Management System, various Quality Operations, Regulatory Compliance, Auditing, Qualification & Validation, Training, Planning & Execution, organizing and managing resources to successfully complete Organizational goals and objectives, while honoring predetermined

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Execution of Risks management system and mitigation plan of identified risks of site in frame of ICH Q9. Proactively identification of Quality Risks and review them and ensure their management through Risk Management System.

Perform self inspection, internal audits & external audits as per schedule & track their CAPAs for their completion and compliance as per approved system.

Preparation and timely review of Technical Terms of Supply documents & Technical Agreements with suppliers for export purpose. Co-ordinate with the exporting country contacts for TTS change control, registration related requirements.

Tracking and review of Key Performance Indicators (KPI’s). Timely support & inputs for achieving Quality KPI targets.

Closely working with GSK Global production system (GPS) and implementation of GPS tools at site to improve site productivity with continuous quality attribute.

Tracking and trending of Quality Project Management actions and monitor their closures by means of mechanisms such as Gannt Charts.

To conduct the necessary programs, impart staff training, mentoring & coaching related Quality updates, GMP updates, 5s, Kaizen, TPM, GPS, GMS, 7QC tools, GEMBA outcome & their related findings for Capability building of site personnel.

MYLAN PHARMACEUTICAL LTD, MYLAN PHARMACEUTICAL LTD, INDIA INDIA Jan 2010 – Oct 2014Jan 2010 – Oct 2014(Mylan Pharmaceutical Ltd – world’s leading generics and specialty pharmaceutical companies, with products in approximately 145 countries and territories)Executive- Quality Assurance Compliance:Executive- Quality Assurance Compliance: Handled the Change Controls, Deviation, Incidence / Failures, Various Non

Conformances, Customer Complaints, Laboratory Incidents/ Investigations of the site. Reviewed of executed batch documents & released product batches in to various

markets. Design, Construction and review of Specifications, methods, Batch documents, RM &

PM documents for Drug products at different stages as per the regulatory requirements.

Preparation and Review of various qualification & validation protocol and reports as per Regulatory requirements.

Actively involved under preparation of Annual Product Review Record & Responsible for the review of Annual product trends & execution of the corrective majors to enhance the Organizational Productivity.

Execution & Monitoring of the Cleaning Validation Activity at the site. Reviewed site SOP’S, Batch documents, method validation documents, Stability

protocols, RM & PM documents for content and compliance with the required regulatory standards.

Facilitate and organize the compilation of applications (ANDA) to regulatory agencies in support of research and marketed products.

Provided regular report of KPI’S to Quality Assurance Management team. Markets Handled US, WHO, Europe, South Africa, Health Canada, PEPFAR, etc.

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UNIMEDICO LAB, UNIMEDICO LAB, INDIAINDIA Oct 2009 – Dec Oct 2009 – Dec 20092009 (Unimedico Labs is a subsidiary group of Unichem Laboratories Ltd which is India’s one of most respected pharmaceutical companies with multi dosages forms)Officer- Quality Assurance:Officer- Quality Assurance: Contributed to and use the company’s risk framework to identify and monitored the

required outcome of potential risks and opportunities in relation to the contract in the specific area of responsibilities.

Responsible for review, Issuance and documentation for validation, BMR, MFR, specifications, Analytical protocols of the finished products.

Responsible for the compilation of the process validation reports & monitoring of the validation batches & Vendor managements.

Vendor Managements (Vendor approval and procurement of necessary documents from vendors TSE-BSE , GMP Certificates, Supplier agreements, specification requirements, MSDS, etc)

SHARON BIOMEDICINE LTD, SHARON BIOMEDICINE LTD, INDIAINDIA Jun 2008 – Sep 2009Jun 2008 – Sep 2009(Sharon Biomedicine – India’s fastest growing pharmaceutical companies, with multi dosages forms) Trainee Officer- Quality Assurance:Trainee Officer- Quality Assurance: Responsible for review of Batch manufacturing records & their Compliance. Monitored all Shop Floor activity during Process Run. Executed & Monitored Competency, Capability of Training Process at site

PROJECTS ACCOMPLISHMENTS PROJECTS ACCOMPLISHMENTS Project completed on Competency, Capability, and Training Process at site (Sharon

Biomedicine Lab, India) TrackWise & Documentum, LIMS software Implantation (Mylan India). Various Operation excellence projects undertaken & accomplished like product

capacity enhancement yield improvements, Manufacturing of product batches with Right First Time (RFT), Reduction of Product Deviation etc. (Mylan India).

GAP Analysis of Quality Management System (GlaxoSmithKline).

PROFESSIONAL EDUCATIONSPROFESSIONAL EDUCATIONSM.Sc Pharmaceutical Chemistry, UNIVESITY H.N.B. GHARWAL, INDIA

B.Sc, Biotechnology, UNIVESITY H.N.B. GHARWAL, INDIA■■■■■■■

HIGHLIGHTS OF PROFESSIONAL DEVELOPMENTHIGHLIGHTS OF PROFESSIONAL DEVELOPMENTGreen Belt Six Sigma, IACT, INDIA

Harvard Manage Mentor course for Business Application, HARVARD BUSINESS SCHOOL, UK ■■■■■■■

SOFTWARE / COMPUTER SKILLSSOFTWARE / COMPUTER SKILLSTRACKWISE, LIMS, DOCUMENTUM, SAP, CDMS

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Microsoft Excel, Outlook, Lync, PowerPoint, Microsoft Word, SharePoint; Windows Microsoft LiveMeeting; Cisco WebEx; Cute PDF; Adobe Acrobat

PERSONAL DETAILSPERSONAL DETAILSName: Name: Anup Kumar RaiAnup Kumar Rai Father Name: Father Name: Ramjee RaiRamjee Rai Date of Birth:Date of Birth: 12th Feb 1983 SexSex: MalePermanent Address: Permanent Address: C/O Mr. Tribhuwan Rai, VPO: Meerpur + Sadat District: Ghazipur C/O Mr. Tribhuwan Rai, VPO: Meerpur + Sadat District: Ghazipur State: Uttar Pradesh, INDIA, PIN-275203State: Uttar Pradesh, INDIA, PIN-275203

Mobile: +91-9168509988 anupkumar.rai1983@gmail.com