Namita Ray - Chattopadhaya

***** *********** ******* ******: 908-***-****

Fremont, CA 94538 E mail: adn2ob@r.postjobfree.com adn2ob@r.postjobfree.com

PROFILE

A highly motivated Quality & Regulatory manager with extensive experience in management of quality, environmental and regulatory affairs. Successfully implemented the ISO 9001-2000, ISO 4501:2018 and ISO 14001:2015 system. Enjoys problem solving, challenges. Audited as both internal and external auditor. The key strengths are providing technical supports to internal and external customers by performing root cause analysis, complaint investigation and effective training. Represented the quality function as an integral part of the strategic planning and management process. Provided directions and leadership to the management by preparing technical reports for management review. Strong expertise in communication, training and building inter personal skills.

PROFESSIONAL EXPERIENCE

Western Digitals, Maintenance & Operation (California) 2019- 2020

IMS (ISO 14001 & 45001-2018) System Manager/ Facilitator/ Coordinator

Implementation of Integrated management system

Developed Document Control system

Prepared & participated in internal and external certification audit

Presented IMS status for Quarterly Business Report (QBR)

Trained managers & employees on IMS

Created Training materials (on power points) for HIRAC, AI & IMS

Developed HIRAC (Hazard identification, risk assessment and Control)

Managed 8D incident investigations and Continuous Improvements tools

Trained on HIRAC & AI (Aspect & Impact)

Developed IMS documentation

Created Document control system

Held IMS team meetings to for internal communications and develop team work

Investigated using 8D tool

Key Achievements:

Successfully completed external audit with no finding

Fully trained employees for the department

G S Cosmeceutical USA Inc. California.

Manager, Quality& Regulatory Affairs 2017- 2018

Directs total Quality of Rx, OTC, cosmetics products and Medical devices.

Maintains and manages the site compliance.

Investigates customer complaint, deviations and non-conformities, develops CAPA and performs verification before closing.

Writes, reviews, and revises Standard Operating Procedures (SOPs).

Review and mange Supplier & Customer Quality agreements.

Leads Process validations, IQ, OQ, PQ and cleaning validation including protocols preparation.

Manages FDA registration of Rx, OTC products and Medical devices.

Manages Manufacturing and Wholesale Drug licenses including Certificate of free sales.

Leads continuous improvement of bulk production,filling and packaging of finished goods.

Key Achievements:

Review and negociate Quality agreement.

Developed company Key performance improvement (KPI).

Leads in continuous improvement of Quality Management and Key performance indicators (KPI).

Leads Annual product reviews.

Designed and coordinated cGMP audits.

Sensient Cosmetic Technologies. New Jersey. 2013 - 2017

Quality Assurance Manager

Managed Quality system.

Implemented IPEC cGMP standards and ICH-Q7 standards.

Managed and reviewed Quality agreements.

Perform and support GMP and internal audit.

Reviewed and managed Quality agreement.

Leads investigation of the customer complaints, root cause analysis and implementation of CAPA.

Support continuous Improvement and process validation

Co-ordinate validation protocol.

Performed monthly KPI reporting.

Key Achievements

Coordinating development of raw material specifications.

Designed and led cGMP audits.

Gave technical support to both internal and external customers.

Manged the site GMP and keep the sie audit ready.

Manages and leads Customer Complaints.

Assisted and coordinated in customer audit.

Leads visit by regulatory agency like FDA.

Cavagna NA, New Jersey. 2012-2013

Quality Manager

Managed Quality agreements and performing annual review of Suppliers.

Coordinated and led ISO audits for the site including Medical devices.

Managed calibration of equipment by third party Suppliers.

Managed total quality system by maintaining Key performance indicators.

Investigated root cause analysis and designed appropriate corrective action.

Supplied technical suupports to external and internal customers.

Developed preventive action as part of continues improvement

Leads internal audit with an objective to continuous improvement

Managed and reviewed customer complaint to determine root causes, and recommend CAPA.

Coordinated customer survey and management review.

Managed vendor rating.

Coordinated lean management.

Presperse Corp, New Jersey. 2009 - 2012

Manager, Quality Control & Regulatory Affairs

Managing Quality Control Department and supervising the quality aspects.

Develops analytical test methods and validate them.

Led the external and internal ISO and GMP audits.

Maintained FDA requirements, 21 CFR (Part 210 & 211)

Managed calibration system for laboratory and production equipments.

Investigated Non-conforming products, customer Complaint and performed root cause analysis by Pareto method

Developed SOP for Quality management and test methods for analytical testing.

Managed purchasing of laboratory equipment, services & safety equipment.

Provided technical support and regulatory information to both internal and external customers.

Coordinated with other departments in maintaining safety at work place.

Key Achievements:

Improving the analytical laboratory by adding major instruments for testing.

Directed continuous improvement by preventive action planning.

Provided timely response to customer’s technical requirements.

Investigated and responded to the Customer complaints.

VERTIS COMMUNICATION, PA.

Manager Quality management system & continuous Improvement & Environmental Specialist

2007

Managing Quality Department and maintained ISO 14001-2004 system.

Responsible for environmental compliances, technical support and environmental reporting of three different sites for different governmental requirements.

Performing and coordinating external and internal audits for ISO 9001-2000 & ISO 14001:04.

Preparing management reports (technical) with trend analysis for the management meetings.

Key achievements:

Development of objectives designed for cost reduction by conducting Waste Stream analysis.

Developed of objectives for minimizing impacts on environment by Source reduction plan.

Performed effective root cause analysis of non conformities.

Developing effective training program.

TEMBEC INC., Quebec, Canada. 1999 – 2007

Manager Quality Control & Environmental

Maintained ISO 9001:2000.by developing quality strategies.

Managing Quality Control Department and maintained ISO 14001-2004 system.

Performing external and internal audits for ISO 9001-2000 & ISO 14001:04.

Responsible for environmental regulatory compliance and did reporting for different governmental requirements.

Managing calibration system for laboratory and production equipments.

Preparing management reports (technical) with trend analysis for quarterly and annual management meetings.

Providing technical support and managing and responding to customer complaint.

Evaluation of Supplier performances.

Performing process and product trend analysis for continuous improvement,

Performing statistical analysis of the finished products.

Tracking non conformities, performing root cause analysis by Pareto method.

Purchasing of laboratory equipments and services & purchasing of environmental service and equipments.

Key achievements:

Performed both internal and external audits (ISO standards).

Implemented and managed ISO 9001-2000 system for eight (8) years.

Developing standard operating procedures (SOP) as per ISO requirements.

Implemented and maintained the ISO 14001-2004 system

Trained and experienced auditor for ISO 9001:2000 and ISO 14001:2004.

Effective cost reduction by efficient negotiations with the contractors & suppliers.

Development of objectives designed for cost reduction and successfully reduced cost by 12%.

Developed objectives for minimizing impacts on environment.

Performed effective root cause analysis of non conformities.

Managed and communicated evaluation of corrective actions.

Developed preventive actions as proactive improvements.

Trained personnel for emergency response plan and WHIMS & OSHA.

Interface with employees to ensure that the current objectives and principles (Quality and environmental) are recognized, understood and met.

HANDY CHEMICALS LTD. (ALCAN GROUP). QUEBEC, CANADA. 1995 – 1998

Quality Controller

Managing Quality Control laboratory,

Handling Non conformity reports, customer complaints,

Performed statistical analysis of the products.

Managing and supervision of documents for shipping of dangerous goods transport (TMD) samples.

Assisting in ISO 9002 audit.

Key Achievements:

Statistical analysis of finished product’s trend to prevent production of non conform products.

Developed and managed projects to study the shelf life of specific products.

Managed projects to study the final performance of specific products.

Prior to working for chemical industries, I was involved with teaching

Physical Science, Chemistry & Biology in adult education & high school in Canada

Head of the department, in an undergraduate college in India.

EDUCATION AND PROFESSIONAL DEVELOPMENT

Diploma in Education (Chemistry, Physical Science and Biology) – McGill University, Canada

Ph. D., Bioscience

M.Sc., Experimental Pharmacognosy

B.Sc., Plant Science, Chemistry, Zoology

Certified IPEC auditor

Certified HACCP

Certified ISO 9001 Lead auditor

Auditor ISO 9001-2000 & Auditor ISO 14001:04

Trained in Six Sigma, GHS and Program STOP

COMPUTER KNOWLEDGE

Word, Excel, PowerPoint, Outlook, Minitab, SAP, CRM, JD EDWARDS, Sales Force, Master Control and other ERP application related programs.

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