Quality Assurance Manager
Resume:
RAJ SINHA
Moseley
VA, ***20
OBJECTIVE Seeking challenging career opportunity.
SUMMARY Practical experience in the production environment with emphasis on effectively
leading personnel, operation and workflow, improve quality standards, ensure safety and cost
control. Extensive experience in Production, Project Management, Quality Assurance / Control,
and Quality Management Systems.
EDUCATION Texas Tech University, Lubbock, Texas
BS (Industrial Engineering)
December 1987
Averett University, Richmond, Virginia
MBA
May 2004
WORK HISTORY
Philip Morris USA
Richmond, Virginia
1/2006 Present
Manager Quality
• Responsible for the effective implementation and successful integration of Quality
Assurance processes to ensure compliance with FDA and applicable ISO standards.
• Participate in strategic planning, goal setting and broad oversight of organization ’s
resources.
• Develop metrics and goals for areas of responsibility and holds direct reports accountable
for results.
• Assist in establishing and directing training programs and continuing education programs
in the areas of quality assurance with emphasis on ensuring that the employee base has a clear
understanding of regulatory requirements and quality systems.
• Organize, evaluate, train, direct, and motivate staff
• Prepare organization charts, job descriptions, goals, and objectives for department
personnel.
• Establish and assure adherence to budgets, schedules, work plans, and performance
requirements.
• Provide timely and meaningful quality reports, information and advice which allows
managers to anticipate and identify potential quality problems and take corrective action.
•Plan, manage and direct plant sanitation procedures, and programs to include HACCP.
•Ensure compliance with operating procedures and regulatory requirements.
•Develop, implement and communicate sanitation plans and activities for all manufacturing
facilities. Develop operating policies and procedures as needed.
•Provide leadership to plant sanitarians, training, and development to optimize their performance,
and evaluate opportunities for continuous improvement in overall sanitation practices.
•Monitor pest and insect control program. Monitor microbiological reports for required facilities.
Determine whether changes/improvements in practices are required.
•Ensure that all standards and procedures are in compliance with PMUSA and regulatory
requirements
•Manage internal audit program across PMUSA and follow up on corrective action plans, and any
identified deficiencies.
•Monitor quality of incoming direct materials and outgoing product
•Establish and maintain product specifications based on process capability and customer needs
•Conduct quality assurance tests and perform statistical analysis to assess the cost of and
determine the disposition for products or materials that do not meet required standards and
specifications
•Participate in the review of engineering designs to contribute quality assurance requirements and
considerations
•Prepare, execute, and analyze manufacturing process validation and process capability studies
•Prepare and execute validation master plan for manufacturing equipment, materials, and new
brands in accordance with change control and PDP process.
•Advise senior management of trends, vendor performance, audit results and corrective action
needed
•Lead investigations to determine root causes of non conformance and assist in development of
corrective actions for containment and preventive actions to eliminate recurrence
•Monitor customer complaints. Develop program to investigate, identify, segregate, and
disposition nonconforming product to assure compliance with regulatory requirements
•Direct and facilitate continuous improvement efforts, using Lean/ Six Sigma techniques
•Utilize tools such as SPC, FMEA, DOE, and process capability studies to reduce variability and
improve quality
12/2004 12/2005
Senior Specialist Compliance & Quality System
•Lead and coordinate internal resources to effectively implement and maintain an effective QMS
(quality management system)
•Manage internal Corrective / Preventive Action process.
•Lead QMS Internal Audit process to assure compliance with QMS requirements
•Develop QMS training and awareness information
•Develop and implement QMS documents to support ISO 9001 Quality System Certification
(Quality manual, procedures, and work instructions)
•Provide a quarterly review of QMS to the management team (verbal and written).
4/2003 12/2004
Front Line Leader
•Maintaining QA/ISO compliance activities including preparation and distribution of reports to
management
•Interfacing with R & D, production and purchasing to resolve problems
•Maintaining budget control, Laboratory safety and regulations compliance
•Assure that quality database is refreshed on a regular basis
•Analyze data and product specifications to determine if works in process and/or finished product
meet specifications
•Manage document control and record control functions for the lab
•Manage lab equipment maintenance program
•Initiate, recommend or provide solutions to quality issues through designated channels
•Retrieving samples and performing physical and analytical tests and preparing activities
appropriate records
4/2001 3/2003
ANALYST
•Responsible for development, implementation and maintenance of Quality System
•Review product parameter performance and interpret data to assure compliance to QMS
requirements
•Identify and address data integrity issues and recommend enhancements
•Responsible for creating and coaching on the QMS Change Process and negotiate consensus
with manufacturing to assure Quality Plan reflect business practices
•Participate in or conduct Quality System Audits
•Member of Incoming Material Acceptance Team for Richmond Processing Plants. Lead efforts to
ensure development / compliance of requirements
•Support/advise/assist Contamination and Sanitation Red Zone Teams to ensure compliance with
Quality System/Regulatory requirements
•Develop work instructions, forms and procedures for manufacturing and Lab
•Coordinate and perform follow up on the Corrective and Preventive activities
•TQM publication on a monthly basis
•Train / Educate hourly and salaried workforce in Quality Systems Principles
Brown and Williamson Tobacco
Corporation
Macon, GA, US
1/2000 4/2001
Senior Quality Coordinator
•Provide leadership, direction, staffing and other personnel related tasks
•Develop staff to ensure cross training and backup capability for all activities and plans
•Coordinate and maintain auditing for ISO requirement
•Determine correct gauges and calibration for each product as defined
•Oversee In process Quality Control functions
•Interface with Manufacturing and Engineering department In Process improvement related to quality
•Continually improving product and service, ensuring conformance to specifications, requirements
and Statistical Process Control
•Retrieving samples and performing physical and analytical tests and preparing activities appropriate
records
•Maintaining QA/ISO compliance activities including preparation and distribution of reports to
management
•Interfacing with R & D, production and purchasing to resolve problems
•Maintaining budget control, Laboratory safety and regulations compliance
•Assure that quality database is refreshed on a regular basis
•Analyze data and product specifications to determine if work in process and/or finished product
meet specifications
•Manage document control and record control functions for the lab
•Manage lab equipment maintenance program
•Lead quality initiatives such as TQM, Six Sigma, ISO and continuous improvements
•Responsible for putting product on hold, sampling and applying accept/reject criteria used for
product disposition
•Lead special Projects assigned by manager
•Supervise Incoming Materials Lab
•Communicate with supplier to address Incoming Material related issues
•Conduct periodic audit of the supplier
•Develop recommendations for improvements that increase product quality and service
•Conduct Quality Audits and present findings/report to management
5/1996 12/1999
Senior Team Leader
•Managing plant production levels including hiring, training and scheduling the work
force
•Manufacturing product according to schedules and specifications, utilizing key
operations to control costs
•Establish and maintain effective working relationships with employees, union
representatives and management staff
•Team implementation and development in labor union environment
•Promote a synergistic work environment using interpersonal skills
•Coaching employees to top performance
•Setting and achieving department goals
•Directing and coordinating all department activities as established by division
policies, procedures and customer requirements
•Budget planning
•Production floor problem solving
•Coordinating government compliance programs including OSHA, safety and
environmental regulations
•Overseeing maintenance of all processing equipment
•Coordination and administration of preventive maintenance programs
•Conduct continual process improvements and maintaining quality standards
•Review production operating reports and resolve related problems
Aramark Corporation
Columbus,Ohio,USA
Production Manager
2/1995 2/1996
Bessin Corporation (Division of Sara Lee
Corporation)
Chicago,Illinois,USA
Industrial Engineer
8/1989 2/1995
Computer Skills: Microsoft Word, Excel, PowerPoint
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