GEETHA KARTHIKEYAN

(M) 096********

E-Mail: fdqmgf@r.postjobfree.com, fdqmgf@r.postjobfree.com

CAREER GOAL: In pursuit of assignments in Quality Assurance/R &D function of a reputed organization, preferably in the FMCG sector ( Foods / Oral Care/Personal Care) and Pharma sector

PRÉCIS

A result oriented professional with 15 yrs experience in Research and Development, Quality Assurance Function , Production processes & 3RD party vendor Audits . Presently working as Research Scientist in Global R&D Colgate Palmolive (I) LTD at their Corporate office ,Mumbai.

Expertise in Greater Asia, Africa, Middle East & India product development process for oral care, home care, personal care products for microbiological robustness & preservative effectiveness.

Expertise in the quality assurance system that covers method and material qualification as well as equipment IQ/OQ/PO, Calibration& Maintenance.

Proficiency in designing Quality control strategies, procedures and methods; diagnosing problems; monitoring and controlling quality control systems to ensure Customer & Regulatory compliance,

Fully Conversant with current Regulatory/Statutory requirement in Oral Care, Personal Care product processes on applicable Indian, BP, USP regulatory requirement & relevant exposure to International std.(USFDA) and have significant exposure to software package eg. SAP

Expertise in setting up Quality Systems, Process validation, Analytical & Microbiological studies of new /existing own & 3rd party manufacturing plants & Vendor performance.

Expertise at maintaining a high level of quality & discipline amongst the work force across manufacturing plant

Significant experience in designing product specification, SOP preparation and implementation & automation

Proficiency in handling Consumer Complaint Management System & ensure CAPA in place to minimise/avoid recurrences

Quality Audits on GMP /Process Validation: Significant wide experience in carrying out various kind of QA Audit in FMCG sector (Oral care/ Personal care -Plant, Raw material Manufacturers, Shops, Warehouse.

Maharashtra FDA approved Microbiologist.

An effective communicator with exemplary analytical & problem solving abilities.

Hands-on experience on Instrumental analysis, Microbiological analysis of various Cosmetics ,Foods products

CORE COMPETENCIES

- Quality & Product Safety - Manufacturing /Operations - Audits/Regulatory compliances

- Strategy Planning - Pest Control management - Training

-Product development - Vendor Development - Resource Planning

- Material Management - Cost Reduction - Benchmarking-Product/Process

- Documentation Mgmt. -Wastage control -Complaint handling management

CAREER HIGHLIGHTS

April 2006 to till date Colgate Palmolive India Limited, Currently working as Research Scientist (Microbiology) in India Global Technology Centre.

In India, Colgate Dental cream is the India’s topmost selling and trusted brand in oral care segment.

Our 200-year of history the Colgate Palmolive Company is manufacturing and selling global brands over 200 countries; Colgate, Mennen, Palmolive, Ajax, Soft-soap, and Hill’s Pet Nutrition are among the world's most recognizable household names, trusted and relied upon by consumers everywhere.

• Overall responsible for developing Standards /Specification /SOP for the microbiology & thereby ensuring product safety, Consumer health safety & Regulatory requirements & Brand image.

• Technology transfer of New Product (FMCG) viz Oral care, Personal care, Home care and Fabric care products.

• Overall responsible for technical coaching to manufacturing sites within the region – specifically site microbiologist’s providing the source of microbiological expertise, training and input to plants helping the plant/site microbiologists to build capability within their own organizations.

• Overall responsible for training and qualification of site microbiologists.

• Overall responsible for microbiological harmonisation compliance across the region and the establishment of a strong network of connections within the Company's microbiological community.

• Carry out review and advice on the implementation and rigor of the individual sites daily management programs.

• Overall responsible for ensuring on time and accurate disposition decision for incoming materials, in-process materials/products and finished products being manufactured in the plant.

• Co-ordinate with the sites testing programs and data acquisition system to provide a regular and detailed status of the regions microbiological performance assuring consistency of standards across sites.

• Responsible for Reviewing and monitoring Micro control statistic data for region and guide sites on the effectiveness of their overall Micro control statistic program to assure alerts and actions are managed effectively as prevention tools.

• Responsible for conducting regular integrated Microbiological risk assessments at each site and be able to help the site develop effective correction and risk mitigation plans. Assure communication the identified risks to the business/es and leadership to ensure understanding and transparency of the risks associated with microbiology

• Overall responsible for Developing, implementing and maintenance of Quality Management System, Environment management System & Product Safety Management system at product development stage, Manufacturing location & at consumer stage.

• Overall responsible for Regulatory compliance like FDA,BIS.

• To conduct Stability Study (accelerated aging, forced degradation, real-time) and post-market surveillance on the products being sold in India markets, as per the applicable regulatory requirements as well as corporate guidelines.

• Carry out Audit(based on product safety /Consumer health/Process Quality /Regulatory requirement) for new start-up approval & routine audits at the manufacturing plant , contract manufacturing sites and at raw material manufacturer sites. Sharing the findings/NC’s with respective Business Head/Category & ensuring timely closure of critical non-conformances.

• Ensuring Monthly Quality Audit on a pre defined checklist on GMP /Regulatory compliance for manufacturing sites. Compilation, trending & sharing the same with manufacturing sites.

• Handling of Customer complaints & root cause analysis .Implement immediate corrective action & explore effective long term preventive measure to avoid recurrence on product safety.

Strive for achieving the customer satisfaction and minimization of consumer complaints.

• Monthly Consolidation of QA reports on Audits.

• Team Building between the QA personnel and work towards improving capability & capacity development.

• Ensuring Greater Asia, Africa, Middle East & India product development process for oral care, personal care, home care, personal care products for microbiological robustness & preservative effectiveness..

• Overall responsible for providing & coordinating for training of plant microbiologist, Vendor microbiologist on relevant sops, GMP & Micro control program and the quality assurance system that covers method and material qualification as well as equipment IQ/OQ/PO, Calibration& Maintenance.

• Ensuring in reducing analyzing number by trending data.

• Responsible for EOHS as a Core Team Member in loss prevention, material management & Ergonomics standards.

• Overall responsible for continuous improvement in implementation of quality standards and guidelines as well as the EOHS standards and guidelines.

• Over all responsible for C&S Standardization in India & Greater Asia.

• Certified as an internal and external Auditor for EOHS & Quality with the CP Audit Skills and techniques.

• Over all responsible in resolving microbiological issues in Research centre and manufacturing plant all around the globe.

• Supported vendor development programme by ensuring compliance of incoming raw materials to C-P specifications.

• Responsible for the stability studies for Oral Care and Personal Care products, set up stability studies, analyze the stability samples and compile the stability reports.

• Responsible in the suspected counterfeit samples to confirm authenticity and issued report to concern.

• Qualified in all the testing parameters in oral care, Personal care like Soap, UAP, and Liquid Hand wash.

• Worked successfully in instrument like Celsis, Agilent HPLC, ISE Fluoride meter, AAS ( Atomic absorption spectrophotometer), FTIR & NMR.

Dec 2003 to April 2006 Colgate Palmolive India Limited, as Plant Microbiologist.

Colgate Palmolive India Limited manufacturing plant in Sewri which annually manufactures 25,000 tons of Oral care products as per the Colgate Palmolive guidelines.

QA/QC responsibilities w.r.t. GMP/FDA/BIS

Managed a team of 3 microbiologist ; assigning them tasks, and motivating them to meet deadlines

In partnership with operations & engineering, developed and implemented plant floor micro control programs based on the GMP, C&S, Control point monitoring (HACCP), and Total Quality Management & Process validation.

Performed internal Quality Audits at the factory.

Responsible for communicating the quality approved status for all the manufactured finish goods in manufacturing plant through SAP to the warehouses so that it is fast & easy to reach the customer.

Implemented effective & cost saving C&S system in the facility.

Over all responsible for the finished product to be released through Celsis advance TM.

Analytically carried out both Microbiologically & chemical methods to meet the desired regulatory requirement as far as FDA & ISI standards is concerned

Developed Sop’s & trained operators in GMP compliance. & created awareness in operators & make them understand risk of contamination Incident.

Responsible for the training of work floor operators for the GMP & microbial insults during making & filling operations which cannot be anticipated are prevented or reduced considerably to ensure safe product.

Prevented or minimized the contamination due to Micro-organisms in Product due to i) Manufacturing equipment ii) Manufacturing Environment iii) Personnel iv) Raw materials v) Bulk & Finished product.

Ensure all the testing is performed according to corporate methods and policy and adheres to good microbiological practices. This includes the set up and administration of a laboratory quality assurance system that covers method and material qualification as well as equipment IQ/OQ/PQ, calibration & maintenance.

Responsible as an editor micro biology magazine.

Responsible for the quality reviews.

SOP preparation for plant quality microbiology operation, Sanitation & GMP/GHP & API requirements.

Responsible for evaluating and bring to compliance the micro susceptibility index in the manufacturing plant.

Process validation for all the product manufactured ,

Prepare Defect classification based on Customer satisfaction, Process capability ,Product deliverable,

Legal compliance for new products & its implementation

FG samples real time study , Control sample review/record as per FDA requirements

Internal /External Audit compliance: Processing, Supplier, Plants, Ware house.

RM/PM/In-process/FG testing/Control sample monitoring of each lot as per Schedule U & system clearance on SAP.

In process/FG defect analysis (Inspection) prior to dispatch, monthly Warehouse visit to check defects status of Finished Product, Reduction of on-line rejection & corrective action.

Cleaning & Sanitation responsibility for entire plants & Implementation of closure of gaps in hygienic practices.

(Water treatment plant, Transfer line, processing kettles, filling machine)

Implementation of effective Plant Pest control program, review & monitoring & ensuring safe product w.r.t. to insect/pest ingress in RM/PM/FG.

Compliance to Weekly production target.

Daily Quality meeting on shop floor to discuss & resolve issues.

Sept’03-Nov’ 03 Dr RC Amin Group of Companies ,

The "RCA Group" is a shipping surveying company and deploys a permanent work force of 373 employees throughout the country besides which also employs over a 100 temporary employees who are engaged mainly at the ports depending on the quantum of orders.

Responsibilities:

Overall microbiological Control of all the goods during & after Shipment.

Micro biological & Chemical Analysis of food product like cereals, pulses, milk product etc.

Key achievement involves of Temp. Condition & Transportation protocol implementation for all the product safe shipment.

April’ 01-July’ 03 Coral Cosmetics LTD. (Contract manufacturing site of Colgate Palmolive) as Plant Microbiologist.

Contract manufacturing company of Colgate Palmolive India LTD. Oral care and Personal care products are manufactured with 10,000 tons.

Responsibilities:

Overall responsible for the IQ/OQ/PQ, maintenance & quality output of the water system unit in the plant.

Overall responsible for the micro control in the manufacturing plant.

Overall responsible for the Factory QC activity of RM/In process/FG analysis –Personal care products, Oral care products and their Batch records ,Control sample retention as per Schedule Q,U & S of D&C 1940act

Instrumental analysis for FG & RM such as GC,IR, UV Spectrophotometer, Arsenic, Heavy metal ,Lead Refractrometer, Karl Fisher , Polarimeter etc.

Responsible for water, finish goods and Raw material analysis for microbiological & chemical parameters as per CP, BIS & FDA Regulatory specification.

Responsible for calibration programme for all chemical & Microbiological instruments

Responsible for the training of work floor operators for the GMP & microbial insults during making & filling operations which cannot be anticipated are prevented or reduced considerably to ensure safe product.

Sep’99 -Mar’ 01 Ace Hygiene Products Pvt LTD as Microbiologist in Research and Development.

Alfaa water purifier manufacturer The UV expert specialize in the design, manufacture and sale of a complete range of UV purification systems, for drinking, process and waste water applications.

Alfaa water purifier manufacturer The UV expert is also the No. 1 manufacturer of Stainless Steel UV water purification systems in India. Alfaa earned the certification of ISO 9001, an internationally recognized model for quality assurance in design, development, production, installation and service, being the first UV water purification company in India to be awarded this certification

Responsibilities:

Over all responsible for developing Industrial & Domestic water purifier models to comply microbiologically and chemically as per ISI standards for drinking.

Designed & developed domestic model water purifier i.e., e- water which is still leading current product for sale in market.

Developed the efficiency of the cartridge & UV lamp.

Developed the efficiency of the carbon.

Responsible for the quality control of the cartridge, carbon, chamber etc.

Over all responsible for handling the customer complaint regarding the quality.

Aug’97-Aug ’99 Kremoint Pharma Pvt . LTD as QC Executive,

Kremoint Pharma Pvt . LTD are actively manufacturing ointments, creams & Gels in allopathic medicines. The range includes burns and antiseptic formulations, analgesic formulation, antiseptic / antibacterial formulations, antifungal formulations, acne pimples formulations, corticosteroid / antibacterial formulations, corticosteroid /antifungal formulations and antibacterial /antifungal formulations.

Responsibilities:

Over all responsible for microbiological department for analyzing water, raw material finished goods both microbiologically and chemically and documenting as per FDA requirements.

Conducted Microbial bioassay of the antibiotics.

Conducted MLT of water sample, Bulk product, finished product as per Pharmacopoeia

Successfully carried out environment monitoring, Sterility testing, stability testing, creating, SOP etc.

Got approved by FDA as Microbiologist.

Control process & Diagnosis techniques

- HACCP

- MSI

- SQC

- RCA

- CAPA

- Validation

- Process audit

PERSONAL ENHANCEMENTS

Awards & Achievements:

Diploma in Quality Control and ISO 9000, NILEM, Chennai 1999.

Diploma in Medical lab Technology. MVE, Mumbai, 2000

Certificate course in computer DTP, Mumbai, 1999.

Maharashtra FDA approval for Microbiology.

First in college at M.Sc .

First in college at B.Sc

ACADEMIC CREDENTIALS

PHD (Microbiology & Chemistry) Pursuing Udaipur university 2011-till date

MSc (Microbiology) 1st Class RKT (Mumbai University) 1997

B.sc (Microbiology) 1st Class RKT (Mumbai University) 1995

SSC 1st Class S.I.C.E.S high School. Maharashtra Board 1989

PERSONAL DETAILS

Date of Birth: 24th June 1974

Martial Status Married

Address: Flat no. 104, Koyna, Plot-16, Sector-15, Palm Beach, Sanpada, Navi Mumbai, Maharastra.

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