Quality Assurance Supply Chain

Rajeev Khajuria CQA, CSSGB, PMP, RAC (Sep ****)

*** ****** **** **, ***********, NJ

860-***-**** (C);*************@*****.***

Professional Summary:

. Supply Chain Quality Assurance Subject Matter Expert, Regulatory

Compliance Leader, Quality Coach and Mentor with sixteen years of

Professional experience in wide range of industries such as

Pharmaceutical, Bio Technology, Medical Devices and healthcare

. Extensive hands on & managerial experience in establishing, operating,

monitoring Supply Chain quality systems for Pharma/Bio Pharma and Devices

industries ;developed & implemented quality processes and procedures for

Supplier management, Change Management, CAPA, Manufacturing,Labeling,Aggregation, Packaging,Warehousing, Distribution and product recalls.

. As leader of the Quality and Compliance (COE) prepared Quality Agreements

with suppliers and partner companies.

. As CAPA Lead for China, ASPAC have ensured to investigate product and

process deviations and develop action plans

. Lead Quality & Compliance teams in identification and implementation of

quality requirements for e -Pedigree, Serialization of Drugs and UDI for

devices.

. Lead teams to develop Supplier Management Plans, SOP's for supplier

API's/materials, supplier qualification and other Quality requirements

from suppliers.

. Lead Quality & Regulatory teams and worked closely with Major Pharma &

Contract manufacturing organizations such as J &J, Merck, Schering Plough

and CMO's such as SHARP/PCI,EISAI and provided quality and regulatory

expertize

. A solid track record in leading teams in auditing and inspections

conducted by FDA, EMEA,CFA,PDMA, MOH for inspections conducted in US, UK,

Japan, China, Korea and India

. Accomplished lean and process improvements for the Quality organization's

ensuring reduction of waste up to 41%

. Extensive experience in the using Quality Assurance techniques such as

Failure Mode Effects Analysis, Root Cause Analysis, Pareto Analysis,

Ishikawa techniques and Qbd

. Extensive experience in training, mentoring,coaching,Quality Assurance

and RA resources on various QARA methods processes and practices including

IND, NDA, ANDA, 510(K) and PMA processes and submissions and corresponding

regulations.

Professional Experience:

Biogen Inc., Cambridge, MA July 2013

- Present

Role: Senior Quality Assurance Program Manager (Global Drug Serialization &

DQSA implementation)

. Lead Validation team within Supply Chain QA (BIIB) to identify, analyze

product Quality & Compliance including (DQSA, Labeling, Packaging,

Distribution and ePedigree for U.S, Hillerod, South Korea, Argentina,

Turkey, China, Saudi Arabia and Brazil.

. Reviewed supplier agreements and worked with BIIB manager to incorporate

Quality requirements (Supplier) within current supplier documentation.

Analyzed gaps in Supplier assessment and worked to finalize SLA

documentation.

. Review of validation and quality documents and ensure that documents are

good for FDA/EMEA inspections.

. Lead the validation team and conducted Global Risk Assessments for system

processes and generated risk assessment report.

. Lead teams in applying GS1 (Supply Chain standard quality requirements)

to BIIB Supply Chain Quality and Business Processes

. Lead teams in resolving CAPA, Implemented Change controls for different

project work streams and applied DQSA (FDA) requirements and developed

processes and procedures to meet Global BIIB Supply Chain requirements.

. Lead quality teams in establishing quality and validation approach,

validation methodology, and acceptance criteria for the drug Serialization

for Hillerod, South Korea, Argentina, Turkey, China, Saudi Arabia and

Brazil.

Accomplishments:

. Provided subject matter expertise in timely completion of Quality and

risk assessments for each Global market. Quality and validation plans were

acceptable to manufacturing and engineering teams at site.

. Established validation approach, methodology, quality deliverables and

acceptance criteria for the drug Serialization program and for sites such

as Hillerod, South Korea, Argentina, Turkey, China, Saudi Arabia and

Brazil.

. Working with Site Quality Leads/ accomplished leaning validation process

and documentation set by 30 percent RCA, Pareto

Celgene Inc., NJ (Jan 2013

- July 2013)

Role: Senior Program Manager (QA & Regulatory Compliance - GMP Systems)

. Established and monitored supplier qualification and supplier management

process and procedures

. Established Quarantine procedures (API); manufacturing, Batch processing/

handling packaging and labeling processes and procedures. Established

processes and procedures for storage, warehousing and product complaints

and recalls

. Improved existing CAPA handling and Change management processes.

Implemented improvised procedures and established new procedures for

internal audits and FDA Inspection readiness

. Developed Audit and Inspection readiness plans for US and European sites

. Reviewed validation and quality documents and ensure documents are good

for FDA/EMEA inspections.

Accomplishments:

. Accomplished leaning of batch and lot processing cycle time of the

manufacturing & production systems by 25 percent

. New supplier qualification process brought improvements in timely

delivery, optimization of quality of Ingredients, materials

General Electric Healthcare (March

2010 - Dec 2012)

Role: Director, Quality & Regulatory Compliance (India, China, ASPAC)

. Established quality system and processes for design, development, and

calibration of Class 1/II/III devices.

. Managed a team of five quality and validation resources that was spread

in markets such as India, China and ASPAC

. Developed standard operating procedures, processes for supplier

qualification, supplier management thus ensuring supplier quality and

performance monitoring.

. Review of all the validation and quality documents and ensure that

documents are good for FDA/EMEA inspections

. Developed standard operating procedures for device manufacturing and

production, storage and warehousing procedures.

(X-Ray MR/Ultrasound/pacemakers and other Implantable)

. As CAPA leader for India, China and ASPAC (Supply Chain) ensured timely

address of CAPA related to Supply chain processes and systems

. Coached quality teams in creating good quality documentation and

provided direction in establishing, documenting, monitoring and improving

Quality Systems.

. Extensive use of GMP's, 21CFR Part 820. Performing, RCA, FMEA, Pareto etc

to analyze Change controls CAPA's, audit and inspection issues and

ensuring that quality systems are in compliant.

. Lead QA teams in India, China and ASPAC in preparation and execution of

inspection readiness plans for, PDMA and CFA inspections in India, China,

Korea and Japan and remediate Non Conformances from Internal audits and

regulatory inspections

Accomplishments:

. Lead QA team and accomplished no major finding for the FDA Inspections in

India,Korea and China

. Lead QA team to Lean the Quality Processes and lean the process to

reduce the waste by 41%

. Awarded GE Hero, Leadership and Subject Matter Expert awards in the years

2010,2011 and 2012

Pfizer PGRDi, New London, CT (Sep 2007 -

March 2010)

Quality Assurance Manager

. Established and managed the GMP Quality systems and standards for

manufacturing, production Batch control, SPL labeling, packaging and

warehousing procedures.

. Managed a team of three quality resources and a team of four to five

contractors in managing GCP and GMP quality assurance domain

. Implemented guidance for meeting compliance with 21CFR Part 11, 21CFR 210

and 211 and ISO 17025:2005 requirements for Supply Chain Systems

. Prepared and managed Quality Agreements for Suppliers and manufacturing

partners that are located Globally

. Review validation and quality documentation, procedures and ensure that

documents are good for FDA/EMEA inspections.

. Established, implemented and monitored processes and procedures to ensure

timely investigation of product complaints and closure.

. As CAPA lead ensured mitigation of CAPA related to Supply chain

nonconformance processes

. Lead the QA team in ISO 9001:2005 accreditation. Maintained technical

standards analyzed audit findings and ensure to meet ISO non conformances.

Role: Sr. Quality Assurance Lead (WT & Quality Assurance)

. Collaborated with different Quality teams and performed Risk Assessment

for products such as for GMP 210/211/21CFR Part 11 and Information

Security Management and responsible for Quality and Compliance of Global

Supply Chain System for all the modules including Vendor Management and

IVR.

. Developed processes and procedures Change management and Change Controls

and Improved the change control process that saved customer 50 % time for

any product configuration changes

. Identified defects and incidents and identified CAPA. Developed action

plans for CAPA and remediation

Wyeth to Pfizer Migrations

. Subject Matter Expert in providing technical guidance and GMP expertize

on product labeling, printing, distribution and storage handling

processes, procedures and work instructions

. Designed,developed and Implemented Production Change Control Plan that

cut down the cycle time of migration processes by 33 %

. Lead the Quality Assurance teams to support Quality audits and reporting

the findings from the internal and quality audits for remediation;

Coached and mentored new hires in quality in order to building competency

for R &D Organizations

Accomplishments:

. Closure on mitigation of Audit actions and ensuring R&D Compliance 2007

through, 2010

. Completing twenty-five Quality Summary Reports for GMP; in shortest

possible time thus ensuring there is no Audit finding from FDA.

Pfizer PGRDi, New London, CT (June 2005 -

Sep 2007)

Role: Senior Quality and Compliance Associate (cGMP Supply Chain and

Genealogy and Drug Serialization Program

. Developed the validation standards for chemical and microbiological

analysis methods and procedures; ensued qualification of equipment for the

manufacturing and production lines

. Implementation and Quality, Supplier and Compliance policies, procedures

in the organization and initiated Lean, Process Improvements and measured

effectiveness.

. Ensured compliance with standards were in compliance with state, federal,

national and international organizations.

Merck & CO, Rahway, NJ (Jan 2002-

Sep 2004)

Role: Senior Quality Assurance Associate (Contractor)

. Developed process for the Quality Control testing for the finished

products and leaned the processes

. Identifying Non Conformances and CAPA remediation plans for CDAS and

defined change management processes and procedures.

. Ensure Compliance with Quality Plan, Suppler Management Plan and

developed procedures for the Product Batch records, Batch testing ;

Ensure IQ,OQ, PQ of the equipment and Stability Testing

Accomplishments

. Assessed,Analyzed and validated the QMS Change requests for Merck /

Schering- Plough Protocol that optimized time and resources and completed

the project in less than six months rather than nine months

Intel Inc. Palo Alto, CA

(Mar.1999- Dec.2001)

Role: Sr. QA Engineer

. Developed QA Strategy,Quality Test Plans,, approach, processes and

development of entire suit plans and scripts

. Led QA Engineers to develop functional and operational and User

Acceptance tests

Accomplishments

. Identifying highest number of defects in the system and working with

developers to find solutions

MEd link Healthcare, Somerset, NJ (March

1996- Mar1999)

Role: Quality Systems Analyst

. Laid out QA Strategy, test framework and QA procedures for Med link

HealthCare business

. Managed user requirements from customer and performed requirement

analysis, requirement elicitation, and requirement validation.

Accomplishments

. Developed Quality verification and validation process for Healthcare

Physicians Portal

Education

. Master of Science(Information Technology, (Majors, Management Information

Systems) completing last 3Papers by Sep2014)

. Diploma in Computer Science

. Bachelor of Science in Law

Certifications

. Certified Quality Assurance and Validation Manager (General Electric

Inc.)

. Certified Lead Auditor 9001:2008 ;Certified Internal Auditor (13485)

;Certified Lead Auditor (-27001)

. Certified Six Sigma Green Belt (General Electric & Quality

Council);Certificate HP- QTP, HP-QC and HP-Load Runner

. Certified Project Management Professional (PMP) Project Management

Institute, USA

. Certified GE Trainer CSV/ QARA, GCP/GMP/GLP/QSR; Certificate in

Microsoft Project Professional 2010

. Certificate in HIPPA (HIPPA Training Regulatory Affairs Certified (RAPS-

appearing- May 2014)

Trainings

. Training in cGMP/GLP/GCP Regulations ( 21CFR, Part 11, 210, 226 - 58 and

820)

. Training in Setup, Quality Report generation for Track wise; Training in

Sarbanes-Oxley (SOX) 404

. Training in Microsoft Office 2010 -Project Server 2010 & MS - Project

Portfolio Server 2007

. Training in ISO/IEC 20000 -IT Service Management and BO 11.0 -Financial

Reporting System

. Training in cGCP cGLP and cGMP FDA Regulations and SDLC / SLC -Waterfall/

Agile/RAD

. Training in ITIL

Contact this candidate