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Years Experience Quality Assurance

Location:
Allouez, WI
Salary:
$120000
Posted:
May 28, 2014

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Resume:

T H I R U MAN I (RAJ IS) P I L LAY

G reen Bay, WI 54301 224-***-**** Cell

r aceb78@r.postjobfree.com E mail

SUM MARY

An independent self-starter, who enjoys challenging projects, this has enabled me to develop

my aptitude in managing multiple projects in the work environment. Able to t ransform

s trategic plans into workable solutions. I work well within multidisciplinary teams by

creating a collaborative environment and leading through influence. Able to articulate and

communicate effectively at all levels. High work ethic, giving 100 % to every endeavor,

committed and reliable. Dedicated, meticulous and can work under pressure. Results

o rientated, self-motivated and manages operations based on operational goals. Excellent

organizational, planning and follow-up skills. Driven by creating innovative solutions and

creating structure in challenging environments.

ED UCAT ION

1995 Post-Graduate Diploma, Analytical Chemistry – U niversity of Johannesburg,

Johannesburg, South Africa

1991 Bachelor of Science ( Microbiology & Genetics) - University of the Witwatersrand,

Johannesburg, South Africa

S U M MARY OF QUAL I F ICAT IONS

• 4 years experience as Chemical Analyst

• 4 years experience as M icrobiologist

• 4 years experience in Method, Process & Equipment Validations

• 15 years experience in CAPA Management

• 12 years experience in Quality Management and developing programs for Quality &

Food Safety systems

• 4 years experience in developing, managing and auditing programs for Safety, Health,

E nvironment, Risk, Quality Assurance & Food Safety Management Systems

• 4 years experience as a Certifying Lead Auditor for Quality, Food Safety, Risk, Health

& Safety, GMP management systems and Product Certification

• 6 years experience in Risk Management – H IRA; FMEA and HACCP

• 8 years experience in Project Management and Lean Six Sigma Black Belt

• 12 years experience in Performance Management

• 4 years experience in Change Management

• 12 years experience in Supplier / Vendor Quality Assurance Management

R AJ IS P I L LAY

• 8 years experience in Regulatory Compliance to FDA and USDA in the Food Industry

• 14 years experience in FDA 21CFR 210-211; CFR 820; Part 11 and CAPA Management

• 15 years experience in Laboratory management

EXPER I ENCE

10/13 - Schreiber Foods ( Manufacturer of Natural Cheese, P rocess Cheese and

C ultured P roducts)

G reen Bay, WI, USA

Current Corporate Food Safety Manager

Responsible to the Food Safety Sanitation Programs Director (Corporate Office)

for 17 domestic plants and 6 international plants

• Dr ives Food Safety compliance across corporate quality field services, plant

quality and leadership staff.

• Supports and enhance the Big 5 program for Food Safety: Traffic Patterns,

G MPs, Infrastructure, Equipment Design and Sanitation.

• Provides technical expertise and ensure compliance for environmental pathogen

monitoring program. Manage all environmental pathogen monitoring data and

t raining.

• Monitors and approves Construction Food Safety plans for appropriate and

consistent content, documentation and execution.

• Coordinates and innovates with Engineering for infrastructure standards,

u pgrades and problem solving.

• Reviews, updates and provides Food Safety t raining for Home Office, Operations

and Technologies teams.

• Provides technical expertise on microbiological test methods and be active in

t hird party lab management.

• Creates and standardizes Food Safety requirements, documentation and

execution of plant processes.

• Assists with HACCP plan reviews and validation.

• Assists with SQF audits at the plants

• Assists with formulation safety reviews and approvals.

• Supports specified customer and supplier initiatives in conjunction with

E nterprise Quality Field Services/Quality Systems/Supplier Quality groups,

Sales, Operations, New Product Development and other functions as

appropriate.

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R AJ IS P I L LAY

• Works with stakeholders to identify gaps and implement robust solutions, i.e.

I nformation System to develop software for Global Environmental Tracking

M odel.

ACCOMPL ISH M ENTS:

1. Achieved 100% ownership of my role in 2 months.

2. Established solid relationships international plants, domestic plants,

engineers, field quality managers, research and development, plant

m anagers and enterprise quality teams for both domestic and international

p lants.

3. Managed Food Safety Construction Plans for infrastructure and sanitary

design of equipment for both new and expansion of plants and distribution

centres. Optimised food safety construction plans for high, medium and low

r isk projects.

4. Optimised engineering standards for infrastructure to food safety

r equirements for different manufacturing environments.

5. Completed gap analysis for design of global environmental t racking

database.

6. Reviewed food safety and pathogen environmental monitoring t raining

m aterial for the business – corporate and plants as well as conducting

t raining for both corporate and plants

7. Aligned 6 international plants to the environmental monitoring program.

8. Managed proficiency testing for plants with accredited external lab.

9. 70% completion of food safety engineering projects for FY14 for domestic and

i nternational plants.

EXPER I ENCE

1/12- McCain Foods ( Manufacturer of F rozen Foods & Ready Meals)

Johannesburg, ZA

6/13 Regional Quality Manager

Responsible to the Regional Supply Chain Director and Global Vice President

• Developed the annual quality & food safety strategy from FY12 – FY14

• Developed the quality metrics and personnel KPI’s

• Developed programs to ensure compliance to legislation

• Managed regional budget

• Ensured product design and compliance

• Provided technical leadership throughout the project lifecycle of new

p roducts

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R AJ IS P I L LAY

• Provided t raining on all global quality policies and projects

• Conducted the following audits at each of the plants – FDA inspections,

A IB Gold, YUM (KFC), McDonald’s SQMS, HACCP, SQF Code (Edition 7),

FSSC 22000 and Global McCain Audits

• Managed CAPA process for internal and external investigations

• Developed and managed the entire supplier/distribution quality

assurance program for local and international suppliers

• Cost of Quality – developed internal, and external failure cost categories

• Ut ilized Lean Six Sigma methodologies for process improvement

• Benchmarked programs against world-class food safety management

systems

• Managed relationships with external customers and developed strategies

t o improve products, services, and internal processes

• Managed and directed activities of quality teams for multiple sites

ACCOMPL ISH M ENTS:

1. Aligned quality & food safety strategy for the region to Global FY16

objectives.

2. Reduced system deficiencies and achieved operational efficiencies by

r estructuring, personnel management and standardizing Quality Structure.

3. Successful execution of quality strategy through alignment of internal

customers.

4. Created standards for legal compliance for high r isk activities at corporate

office.

5. Aligned all H igh Risk Suppliers to GFSI Schemes.

6. Eradication of Pathogen Contamination at one of the plants – R2 million

r eduction in test costs.

7. Redesigned Flake Line and Line 2 to achieve safer product, better line

efficiency and to improve the f low of waste.

8. Developed recall & t raceability requirements in line with legislation and

converted on-going “FAIL” into “PASS” status for finished products and co-

products.

9. Achieved audit compliance from consecutive audit failures by redesigning

key food safety and quality programs.

10. Improved customer relationships for top 6 customers.

11. Transitioned the vegetable division to a GFSI audit scheme – FSSC 22000

and reduced number of audit days to 6 per annum.

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R AJ IS P I L LAY

12. Increased the implementation of McCain Global GAP (Good Agricultural

P ractices) by 40%.

13. Achieved an award as an active member of the global quality leadership

t eam for significant contributions.

14. Exceeded global compliance target by 10%.

15. Removal of french fry plant from McDonald’s watch list.

16. Reviewed specifications for vegetable division to achieve a 40% reduction in

t he number of SKUs for the division.

4/09 - Nampak Packaging ( Plastic & G lass Packaging Manufacturer for Food,

Beverage & Cosmetic I ndustries) Johannesburg, ZA

12/11 SHERQF Manager (Safety, Health, Environment, Risk, Quality & Food Safety)

Responsible to the Managing Director

• Developed annual SHERQF Strategy from F Y09 - F Y12

• Maintained legislative compliance and enforced SHERQF legal

r equirements

• Developed an integrated SHERQF management system that achieved full

compliance for – HACCP, ISO 14001, ISO 9001 and OSHA

• Managed area KPI’s – monthly reporting to Board of Directors

• Conducted internal and external audits

• Created and solved QHSE system non-conformances with CAPA process

• Conducted r isk-assessment based on H IRA, HACCP and FMEA

methodologies

• Ensured Process Improvement using lean six sigma methodologies

• Conducted annual SHERQF management review

• Managed budget for r isk compliance of plant and SHERQF department

• Managed supplier quality assurance for raw and packaging materials

• Trained and coached process owners and developed all t raining material

• Developed and managed key performance contracts

• Managed activities of contractors (including Furnace 2 Rebuild)

• Responsible for Facilities Management

• Managed performance of SHERQF team for multiple sites

ACCOMPL ISH M ENTS:

1. Replaced poor performers and services by restructur ing the SHERQF

department.

2. Received insurance payout of approximately R4 million from sub-contractor’s

i nsurers for defective product.

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R AJ IS P I L LAY

3. Improved safety and environmental compliance for business from 60% to 92%

for group r isk insurer – Alexander Forbes.

4. Achieved full audit compliance from Coca Cola as an Approved Supplier.

5. Reduced Customer Complaints by 30% by improving inputs into the glass

m anufacturing process.

6. Reduced DIFR (injury rate) from 4.0 to 1.5 by designing key health and

safety programs.

7. Improved security and fire defense across the business which uncovered

t heft of weigh-bridge – R27 million and theft of electrodes – R600000.

8. Conducted contract reviews and provided savings of R1.75 million.

9. Conducted several disciplinary inquiries with favorable outcomes for the

business.

10. Designed a t raceability program from receipt to dispatch through JDE

(system f low) to ensure 100% recall t race.

11. Converted waste streams from a hazard to a revenue generating commodity.

12. Rescued laminate business unit from closure with successful completion of

cGMP Implementation as an approved supplier for GlaxoSmithKline

11/05 – South African Bureau of Standards ( Food, Beverage, Chemical & Health

Certifications) P retoria, ZA

3/09 Q uality, Food Safety & Risk Lead Auditor

Responsible to Food and Health Certification Manager

• Conducted Third Party Certification Audits

• Performed assessments and certification audits for new and existing

clients for food, beverage, pharmaceutical, and medical device sectors

• Performed contract review, audit costing, planning, schedules, reports

and follow-up

• Handled customer concerns in accordance with divisional procedures

• Ensured accreditation of certification body by complying with ISO17021–

conformity assessment

ACCOMPL ISH M ENTS:

1. Registered ISO 9001:2000 Lead Auditor with SABS

2. Registered SANS 10330:2007 Auditor with SABS

3. Registered Product Certification Auditor for Packaged Water – SANS 1862

4. Registered ISO 22000:2005 SABS Lead Auditor

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R AJ IS P I L LAY

5. Registered ISO 9001:2000 SAATCA Lead Auditor

6. BRC Auditor (2005)

7. ISO 13485 – Quality Management System for Medical Devices Auditor

8. ISO 14791 – Risk Management for Medical Devices Auditor

9. OHSAS 18001:2007 – Occupational Health & Safety Management Systems

A uditor

10. Grew customer base by 42% in the Food & Beverage Sector

11. Grew customer base by 53% in the Pharmaceutical Sector

1/02 – L’Oreal ( Haircare & Cosmetic), Johannesburg, ZA

10/05 Q uality Management Representative

Responsible to Industrial Director

• Achieved full quality system implementation across all processes of the

business.

• Developed quality strategy under supervision from headquarters in

F rance

• Conducted quality incident investigation from receiving to dispatch

• Managed production/quality meetings

• Managed customer complaint process

• Monitored the progress of quality surveillance on shop-f loor by

performing daily audits

• Mapped processes for physical f low of goods for receiving, dispatch and

subcontracting

• Developed material and completed t raining for all levels of personnel and

subcontractors

• Led the Steering Commit tee on quality review and monthly operational

objectives

• Reviewed packaging and finished-product specifications

ACCOMPL ISH M ENTS:

• Achieved 90% execution of quality control for production.

• Improved supplier quality assurance audit program from -59% to -11% for

t op 5 suppliers of all packaging.

• Re-designed quarantine, weighing and raw material f low to maximize

efficiency.

• Succeeded in obtaining e-mark (SABS) for all products for export to the EU.

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1/94 – R OCHE Pharmaceuticals ( Pharmaceutical, Fine Chemicals, Vitamins &

F eed I ndustry)

12/01 Johannesburg, ZA

C hemist; M icrobiologist; Quality Assurance Co-ordinator

Responsible to QA Manager

Assayed OTC, Scheduled 1-4 drugs, multi-vitamin products, premixes and

animal feed using Wet Chemical Techniques, Potentiometric Determinations,

D issolution Testing, Atomic Absorption Spectroscopy, Atomic Emission

Spectroscopy, Gas Chromatography, HPLC, UV absorption Spectroscopy,

F lourometric Determinations, Dissolution Testing, Thin Layer

Chromatography and Infra-Red Absorption Spectroscopy

Tested raw materials, finished products, packaging containers and premixes

for microbiological puri ty

• Performed quantitative analyses of Vitamins A, E, B1, B2, B6, Ascorbic Acid,

N icotinamide, and Calcium-D-Pantothenate in premixes and Lasalocids,

feeds, cereals and meat

Performed stability testing

Conducted Equipment, Method and Process Validations

• Managed in-process control in packaging and production

Conducted environmental monitoring

Ensured investigation of out-of-specification results

Controlled reference standards program

Conducted internal audits to comply with cGMP and external audits for

M edicines Control Council

PROFESSIONAL CERT I F ICAT IONS

• Risk Management Qualification & Risk Auditing P ractitioner ( IRCA)

• Registered I nternal and Supplier Auditors (AS9100)

• Lean Six Sigma Black Belt

PROFESSIONAL COURSES

• Project Management

• Change Management

• Leadership, Business Principles & Skills (Argil)

• Good Manufacturing P ractice for Quality Control (cGMP)

• Good Clinical P ractice (Wits Health Consortium & Quintiles)

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R AJ IS P I L LAY

• Clinical Research - The “ABC” of Quality Cont rol (Wits Health

Consortium)

• M icrobiological Techniques

• Legal Liabili ty

• Quality Management & Supplier Management (L’Oreal France)

• Advanced Safety, Health, Environment Management (SAMTRAC)

• FSSC 22000 & PAS 223

• ISO 14001

• REFERENCES - F urnished upon request

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