PROFESSIONAL SUMMARY:

• Buisness System Owner for Site Quality Reviews, EMQA (Specialty Care)
• Secondary Business System Owner for CAPA & Deviations Systems, EMQA, Specialty Care External Supply (SCES)
• Business System Owner - Data Integrity & Data Integrity Champion, EMQA (SCES)
• Business Quality Representative for Computer Systems for EMQA, (SCES)
• Buisness System Owner for Adobe Sign (GxP) for EMQA, (SCES)
• Quality System Lead for Computer Systems (Labware LIMS, Veeva DOCS, Tracelink Labeling, Catsweb and Phenix Deviation, CAPA and Change management Systems)
• Leader in establishing, implementing, and monitoring Quality Systems defining Standards, Governing Procedures, Procedures, Guidance documents, Gap & Risk Assessments for Pharmaceutical, Device and Biotech products
• Lead Quality System teams in establishing and implementing Processes, Systems for Drug Testing, Manufacturing, Packaging, Labeling, Quality Assurance, Logistics and Distribution
• Quality System Trainer for Deviations, Change Management, CAPA, Data Integrity, Computer System Validation, and related processes in line with 21 CFR 210, 211, 820 and Part 11
• Lead Quality System teams in Internal Audits, Inspections, Self-Inspections, Third party Inspections and External Inspections for FDA, EMA, MHRA Inspections.
• Lead teams to design, develop and implement Integration of GxP & Quality related data for Computerized Systems having Deviations, CAPA, Change Management, GxP Records, Product Complaints or GxP Electronic Records

TECHNICAL SKILLS:

QMS Trained: Trackwise QMS, Veeva QMS, Phenix QMS, CatsWeb. DMS Trained Documentum, Veeva Quality Docs. Supply and Materials Management,, Microsoft Project Professional 2010 (Microsoft Global Partner). Others a) Speaker at DIA Annual Conference (May 12, 2015), PA, “GCP/GMP - Regulatory Inspection Readiness" to 500 Industry Leaders / Professionals from Pharma, Biotech and Device Industry

PROFESSIONAL EXPERIENCE:

Confidential

Manager, Quality Systems

Responsibilities:

• Established a robust Deviation and CAPA review process for the deviations entered by the CMs and CLOs for Drug Testing, Drug Manufacturing, Drug Packaging and Labeling, Drug Distribution, and Logistics standpoint
• Collaborated with SCES Process Owners and Improvised the Weekly Reporting of the Deviation and CAPA Metrics process.
• Coming due and Overdue deviations and CAPA were taken up with the process owners which reduced the closure time by 30%.
• Initiated a new process at SCES for Gaping the Deviation & CAPA Local Procedure with the Global Standard and thus ensuing 100% coverage of the process requirements.
• Developed an improvised framework of the Governing procedures, Local procedures and the Guidance documents and ensured 100 % of the SCES employees and contractors
• Reviewed QTAs and worked with CMOs, CLOs to ensure that Deviation and CAPA requirements are understood, challenges addressed and ensure to enhance the Process on a continual basis
• Word with department for the development of Materials for CBTs, OJT, Job Aids and developed Curricula and employee, contractor assignments
• Collaborated with Global DI Program to develop Data Integrity Maturity Model program for Sanofi.
• Developed DI Governance Framework (Standard, Governance Procedures, Local SOPs, Master Plan for SCES, and ensured 100% compliance with the Quality System requirements
• Developed Curricula and ensured 100% compliance with s. Conducted DI Awareness Sessions
• Put a process in place for Quarterly review of DI Master Plan and DI scope at SCES. Has been able to include Contract Manufacturing Quality operations, Business Operations. Supply Chain and Logistics into scope.
• Established a Quality system framework at SCES and introduced periodic review of User Access, Audit Trails, and Segregation of Duties
• Established the process and Implemented Adobe GxP System for all the SCES Global sites. Trained Site user to use the System for all GxP electronic record approvals for CCRs, Deviations, CAPA etc. Developing/ Executing Mock Audits and ensuring regulatory compliance with cGMPs, 21CFR Part 11, 21 CFR 820, ISO 13485/14971, ISO 9001, ASTM 2500, GAMP-5, and ICH guidelines.

Business System Owner

Confidential

Responsibilities:

• Re-designed, established a robust Site Quality KPIs for 30 new Processes from Testing, Product Quality Reviews, Manufacturing Batch Record reviewees, Product Quality Events.
• Developed a new Quality System and Compliance approach and governance framework that ensured a sustained compliance with the Sanofi-Global Standards and FDA/EMA Regulatory Requirements.
• As a result, developed Governance Procedures, local SOPS and Guidance documents and ensured s for SCES sites globally
• Introduced a quarterly review of the KPIs with the System Owners and ensured that metrics are developed and reported at the QMR meeting accordingly
• For putting a Robust QMR System at SCES has been acknowledged and appreciated by the Sanofi Chief Quality Officer, Global BU, and Quality Heads at the last two Annual Site Quarterly Reviews

Confidential

Senior Quality Manager

Responsibilities:

• Improvised Change Management System (EU, US and ASPAC Sites) for 33 Global Manufacturing Sites
• Brainstormed and Identified pain points for 33 Manufacturing Sites/ RA organizations and developed a plan to improve the processes and mitigate the pain points.
• The changes in the process and Simplification of the procedure improved the KPIs by 30 %
• A Global Change Management Standard, Governing Procedure was developed that Sites would be required to align
• Developed Business Case, and DI Strategy for the Organization Globally.
• Developed DI Governance Team to meet quarterly and ensure Adherence to DI Road Map and DI Master Plan
• A new Governance Structure (Standard, Local SOPs were put in place.
• Identified third Party Vendor (PQE) to perform Pilot DI Assessments at major Sites in US, EU, and Canada
• Post Assessments, lead to identify Short Term and Long-Term Remediation/action plans and remediated the Risk
• Ensure DI s for all Employees and Contractors and ensure 100 % as well as conducted DI Awareness sessions, Webinars etc.

Quality Assurance Lead

Confidential

Responsibilities:

• Lead QS team, collaborated with RA/CMC team and ensure that Confidential for Drug & Device Products is successful
• Defined a new Change Management Governance process for the Oncology NBS, revised existing procedures and guidance.
• Developed a new process for MinTek and Minova (Safety Systems) to monitor change controls and ensure timely implementation of the Change Controls
• Quality Auditing: Audit and Inspection Systems, track wise, Change Management/ Remedy, HP-ALM
• Responsible to develop KPIs for QMR processes and worked with the System owner to implement the process
• Responsible HCLLDS & perform pFMEA/Risk Assessments and identify risks associated with secondary labeling of 14 top products. Developed Master Plan& implementation of Secondary Labeling and on14 Manufacturing lines and products
• Identified risks during the process of implementation of labeling and mitigated risks

Confidential

Quality Manager & Quality Process Lead

Responsibilities:

• Defined processes and procedures for product serialization so that CMO’S (Sharp, PCI, Alkermes) could perform product serialization. Responsible to perform, pFMEA for Automated Manufacturing Systems, Systech, Inspection Systems, Laser Systems and conducting 21CFR Part 11 assessments (GMP Systems)
• Responsible for the establishment of Quality and Validation Strategy for the Global Serialization program for the three major drugs marketed in U.S, Norway, China, Korea, Brazil, and Saudi Arabia Markets

Confidential

Leader, Quality and Compliance

Responsibilities:

• Defined Quality Strategy and designed the process for Quality Systems Change Management. CAPA and deviations. Identified CSV Processes, Global Procedures and Guidance
• Responsible for Inspection readiness (GEHC, cGMP Systems) for FDA inspections at facilities in India China, Korea, and Japan and worked closely with Site QA, Product Owners, Engineering and Senior Management to ensure effective handling of the inspections, resulting with no major findings or warning letters for the GEHC
• Applied Kaizen and Lean Six Sigma and leaned GEHC quality and compliance Processes above 40%
• Established Quality Manager/Validation Manager program at GE HC to enhance competency, expertise. Established GxP Compliance Program for ASPAC for the first time ed GE Hero, GE- Leadership, GE- Subject Matter Expert and GE-Inclusiveness s for the year 2011 and 2012

Confidential

Product Quality Compliance & Quality PM (GMP/GCP)

Responsibilities:

• Developed Production Change Control Process that cut down on the GxP validation activities by 50%
• Defined Quality System process for Product Quality & Compliance organization. Established procedures for Deviation Management, Segregation of Duties, User Access Management and Audit Trails.
• Collaborated with ITS to establish & Test Disaster and Recovery and Back up & Restore procedures and developed procedures for (21 CFR 210, 211, 48,50,54,56,58Part11, Owner for Clinical Protocol and Registry System, Pfizer Trials, One Site Monitoring System GMP Systems
• Developed Process for Investigating incidents, raising, and implementing CAPA that helped to close CAPA in advance
• Developed Process and Materials for Deviation Management, Change Management, Segregation of Duties, User Access Management and Audit Trails