Quality Assurance Control

Kavitha SampathKumar Summary:

Quality Assurance professional in a Pharmaceutical manufacturing company, Sterile Pharmaceutical company and Tissue Culture Lab

• 5+ years of experience in Quality Assurance related work - Tablets, Capsules, Liquid, Injectables, Food products, Infant Formula and Adult Nutritional products

• Skilled in 21 CFR, CAPA and ISO 9000 Quality Management, Documentation systems.

• Class 100 (ISO 5) qualified. Aseptic techniques, cGMP, GLP practices, Validation and SOP’s.

• Processing Change Requests, Batch record reviews, Retains sample management, Infrastructure of the product development, Inventory Management, Root Cause Analysis,.

• Assisted with regulatory inspections (FDA/DEA authorities)

• CAPA investigation, internal audit, Final Product Disposition, Final approval for shipping.

• Six Sigma Methodology, AS400, Citrix, QDMS, Lotus Notes.

• Windows Operating System, Microsoft Office Suite, Tharo Easy Label, Microscan ESP,

EDUCATION:

Bangalore University

Bachelor of Science

Degree Emphasis: Microbiology, Chemistry and Botany.

Certification:

1) Six Sigma Greenbelt,

2) RAC.

EXPERIENCE:

Abbott Nutrition, Columbus, OH April 2012 – August 2012 April 2012 - Till Date

Quality Assurance Project Specialist

Abbott Nutrition is headquartered in Columbus, offers trusted products including leading infant formulas and pediatric brands as well as its entire line of adult nutritionals.

• Create new documents in QDMS and reviewing them and verifies the Change document (red line) is complete and signed according to document control.

• Issue the documents to production in AS 400 and QDMS.

• Process, approves Change Requests, Proof reads and routes for review and Approval

• Processing the Change Requests for Original Issuance and FLTS.

• Ensure the Registration, IFA and Sterilization assessments are obtained for the Change Requests depending on pediatric and adult nutrition products.

• Make proper changes in AS 400 according to redline document and add AS400 pdf documents to QDMS

• Completing the query codes definitions for approved batch calculations when requested by the plants

• Creating and Maintaining In-Process Authorized Combinations (IPAC) as guided by Product Assurance, when requested by the plants.

• Maintaining the division change control for mainline programs, subroutines, formula factor sets by reviewing, processing, and verifying the changes.

• Processing the documents for Critical Parameters (Master specs and Ingredient specs), Factor sets and Batch Calculations, Shelf life, valid range list by Commodity, Process list, Nutrients in Commodities by Commodity.

• Guiding Associates from different department regarding the proper Documentation procedures.

Nestle Quality Assurance Centre, OH December 2011 – April 2012

Microbiologist

Nestle Quality Assurance Center (NQAC) is a key analytical and technical functions unit for all of Nestlé’s businesses in the America.

• Evaluated, developed, implemented, and maintained QA micro testing

• Reviewed laboratory records in accordance with Good Laboratory Practice standards

• Conducting quality control testing for Listeria, Salmonella, and E. coli on finished products, raw materials, and environmental swabs.

• Ensure the Salmonella samples ph. for proper growth.

• Microbiological lab investigations including deviations, CAPA and Root cause Analysis

• Worked under HACCP implementation,OSHA compliance including workplace safety training

• Recorded Safety observations on the BBSO.

• Implementing 5S in Lab

PharmaForce (subsidiary of Luitpold Pharmaceuticals) July 2010 – June 2011

Quality Assurance Associate

PharmaForce is a sterile pharmaceutical company that produces injectables, ophthalmic and cytotoxic products. The drugs are manufactured under US pharmacopoeia and strict sterile conditions.

• Ensure all work is performed and documented in accordance with existing company policies and ISO 9000 guidelines.

• Followed 21 CFR (parts 210 and 211), cGMP, and health and safety requirements.

• Performs routine in-process quality checks of production activities, filling, including line clearances, sampling, product inspection, label and component issuance, material disposition.

• Component testing, dimensional testing and issuance for further chemical and microbial testing.

• Management of the retain samples.

• Provides on-the-job training and reinforcement for both Quality and Operations personnel in aseptic techniques, gowning and documentation.

• Manages the approval and release of FDA and DEA approved Pharmaceutical products for shipping.

• Was an active member of the team of CAPA and CAPA activities for root cause analysis, investigation and implementation of CAPA.

• Prepared the Internal Audit schedule and coordinated with the team for Self Inspection. Prepared the observation and compliance report for improvement in Quality System

• Reviewed Documents like Batch Manufacturing Records (BMR), Batch Packing Records (BPR),Log Books, Bill of Materials(BOM),Certificate of Analysis, Certificate of Compliance and MSDS

• Prepared Annual Product Quality Review Reports

• Ensured periodic validation and Re-Validation related to process and Equipments/Instruments whenever required.

• Inventory management of raw materials and packaging materials and ensured stock rotation requirements like FIFO AND FEFO.

• Assisted department head in developing Systems, SOPs and documents as per GMP requirements

• Environmental monitoring quality assurance. Performed airborne particulate monitoring

• Statistical process control and application of statistical thinking to problem solving;

• Ensured optimum productivity in team work in the department.

Was not authorized to work in US due to dependent Visa March 2006 – March 2009

Falma Pharmaceuticals October 1997 – April 2001

Quality Assurance Associate

Falma Laboratories (P) Limited, established in the year 1988 is an integrated Healthcare company. Falma offers unique advantage of wide range of branded generics coupled with specialty products.

• Worked in tablet and capsule manufacturing area as well as liquid section.

• QA testing during manufacturing in tablet/liquid departments.

• Filled up cleaning report for Multi mill, Mass mixer, planetary mixer, Shifter, Compression machine, fluidized bed dryer, Tray drier.

• Maintained Cleaning schedule of Tablet manufacturing department which includes fly-o-site, Air Conditioner, Racks of punches, Tube lights, Fan, Electric fittings, exhaust fan, dehumidifier, deduster.

• Fumigating the manufacturing & packing area and record the same.

• Given Manufacturing line clearance and recorded line clearance reports.

• Sampling Raw materials and packaging materials.

• Submitted samples to Quality Control department for in-process bulk testing.

• Carried out in-process testing of tablets for average tablet weight, hardness, thickness and friability.

• Maintained Quarantine records.

• QA testing on completed product like randomly checking the weights and physical structure of the tablets.

• Component testing and issuance for further chemical and microbial testing.

• Conduct and ensure that the CAPA investigations and reports are accurate and completed.

• In process checks for labelling raw materials and finished products, Blister packing, carton packing and shipper packing.

• Collected the retains and maintaining the retains and documenting accordingly.

• Daily involvement in all QA/QC matters from SOP revisions to daily controls.

• Managed a team of 3 people; assigned tasks, and motivating them to meet deadlines.

• Solved major quality assurance problems which temporarily halted production.

Khoday Bio-Tech Lab August 1995 – September 1997

Quality Assurance Analyst

Khoday Biotech is a Research and Development, production of Hybrid Seeds in Vegetables, Flowers, Agronomic crops like Sunflower, Cotton and Rice, Ornamental plants, Biotechnology products and construction of Greenhouses.

• Maintaining cleaning and sterile schedule for media preparation.

• Quality assurance of the growth of the different variety of plants and checked for microbial and fungal growth in the media

• Supported interrelated activities in product development, including checks in sample preparation and sample tracking, and advancing plants to the green house.

• Recommended technical improvements related to cell culture, transformation and media preparation.

• Knowledge of aseptic techniques and plant tissue culture methods and practices, as well as general understanding and application of scientific principles, theories and concepts in the field of plant tissue culture and transformation, HPLC, pH meter and wet chemistry methods.

• Maintained accurate documentation of the inbred evaluations, parent pedigrees, all inheritance information, clones maintained in tissue culture, current status of items in test production.

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