Project Manager
Resume:
RAJESH PATEL
Fort mill, SC-**715
Phone– 864-***-**** (cell), Email- *******@*******.***
OBJECTIVE:
Seeking a challenging position as a MICROBIOLOGIST in the pharmaceutical/ Biotech industry, where I can use my skills & education to the best of my abilities & work in a positive team environment.
EDUCATION: M. S in Microbiology (1995)
B. S in Microbiology (1993)
Diploma in Pharmacy (1989)
SUMMERY OF EXPERIENCE:
1) Recent working for USDA- NSL Jun. 2010 to till date
801 summit crossing place Gastonia NC working as Microbiologist
USDA- NSL (united state department of agriculture- National science lab.) Science and Technology Programs provide scientific and analytical support services to the agricultural community to improve the quality, wholesomeness, and marketing of agricultural products.
Maintain documents according to protocol, SOP and lab books.
Possess excellent aseptic techniques to prevent contamination during testing procedure.
Preparation of culture Media like weighing, hydrating and plating of microbial growth media.
Operation and validation of the autoclave to ensure that equipments, liquid loads and decontamination materials are properly sterilized
Performing Growth promotion test of Nutrient and selective media/agar.
Preparation of daily bacterial culture by sub culturing from stock culture.
Perform test of agriculture commodity samples like eggs, dried milk powder, lettuce, jalapeño, cappuccino, Milk shake powder for E.coli ,salmonella , standard plate count and E.coli 0157:H7
Conduct daily cleaning study of work bench using swabs and expose media cards according to protocol.
Equipment Operation- Incubators, pH meter, Dry heat sterilizer, Balance, Colony Counter, Steam sterilizer (autoclave) and Laminar air flow bench (LAF).
2) CANADIAN CUSTOM PACKAGING (CCP) Nov.2005 to Dec.2009
333, Rimrock drive, Toronto, Ontario, Canada as a Microbiologist.
Canadian Custom Packaging Company is a contract manufacturer specializing in the design, manufacture, and packaging of products ranging from cosmetics, pharmaceutical creams and ointments to sterile eye products. http://www.cdncustompackaging.com
Writing and reviewing of test method protocol, reports, SOP, OOS and lab books.
Maintain documents according to cGMP and GLP.
Assist and interact with other department- production, compounding as needed.
Possess excellent aseptic techniques to prevent contamination during testing procedure.
Gram staining of contaminant and positive bacteria.
Preparation of culture Media like weighing, hydrating and plating of microbial growth media.
Operation of the autoclave to ensure that equipment & liquid loads are properly sterilized
Performing Growth promotion test of Nutrient and selective media/agar.
Performing conformation test of USP standard Quanticult culture.
Disposal of contaminated media after proper decontamination cycle of autoclave.
Sampling of purified water, raw materials and finished product for microbiological test.
Testing of purified water for detection of bioburden-total aerobic count and pathogen like E.coli ,salmonella sp., Pseudomonas aeruginosa and s.aureus species
Perform settling plate count and Air viable particulate testing in class 100, 100,000k & control areas using MAS 100 sampler.
Perform microbiological test of raw material and finish product according to SOP, USP, Natural Health Products- Health Canada and CTFA guidelines.
Monitor personnel hygiene during sterile operation by gowning and finger tip count load.
Monthly monitor’s particle count in 100, 100,000k area by Met-One particle counter.
Perform preparatory testing of the pharmaceutical products to validate the test method.
Perform Microbiological limit test of Cosmetic / pharmaceutical samples of raw materials, stability and finished products for detection of bio burden (total aerobic count and yeast/Mold) and objectable organism like E.coli ,salmonella sp., Pseudomonas aeruginosa and s.aureus species.
Perform sterility test of sterile eye wash product and sterile environment swabs by traditional membrane filtration method.
Conduct cleaning validation of reactor using swabs, contact slides and rinse samples of manufacturing equipment according to protocol.
Equipment Operation and calibration- Incubators, pH meter, Dry heat sterilizer, Balance, Particle counter, MAS air sampler, Colony Counter, Steam sterilizer (autoclave) and Laminar air flow bench (LAF).
3) NOVOPHARMA (TEVA, USA) May.2003 to Nov. 2005
5691,Main street @stouffville, Ontario, Canada as a Production technologist in Coating Department
Novopharm Ltd is a member of TEVA group which is the largest generic pharmaceuticals company in the world. http://www.novopharm.com
Perform all duties as per described in Batch Manufacturing Record (BMR), standard operating procedure (SOP), standard cleaning procedures (SCP’s) and GMP.
Involved in dispensing of active and non-active Raw materials, coating , stage wise yield calculation, label and weigh finished product as per SOP’s and proper documentation.
Avoid products cross contamination by following cGMP and SOP.
Cleaning, sanitizing and operation of various manufacturing machineries as per SOP
Involve in operation, maintenance and cleaning of coating machine, Mixers, S.S. kettles and Homogeniser etc.
Experienced in trouble shooting in case of machine default.
Involved in investigation for deviation and out of specification (OOS) results
Follows & maintain cGMP, Standard Operating Procedures (SOP), health and safety policies
Enter test result in to LIMS in order to transfer product for packaging.
4) CADILA Healthcare Ltd. Apr.- 1999 to feb.2001
Position: Quality Control- Microbiologist
Cadila Healthcare is one of the large Pharmaceutical company; it is engaged in manufacturing healthcare products such as vaccines, Anti-TB kits, liquids, sterile and nonsterile dosage forms. http://www.zyduscadila.com
5) AVENTIS PHARMA, Mar. 1996 to Mar. 1999
Previous called HOECHST MARION ROUSSEL Position: Quality Control- Microbiologist
Aventis pharma is the world leader in the pharmaceutical business and one of the brand name vaccines manufacturers in the world. http://www.aventispharmaindia.com
Writing and reviewing of test method reports, SOP, protocol, OOS and lab books.
Assist and interact with other department- production, compounding as needed.
Possess excellent aseptic techniques to prevent contamination during testing procedure.
Gram staining of contaminant and positive bacteria.
Perform microbiological assay of antibiotics (Roxithromycin) by cylinder plate method.
Prepare stock solution, test solution and B.subtilis culture by Roux bottle method.
Reading of test results by measuring zone of inhibition by venial calliper or ruler.
Preparation of culture Media like weighing and plating of microbial growth media.
Operation of the autoclave to ensure that equipment & liquid loads are properly sterilized
Performing Growth promotion test of Nutrient and selective media/agar.
Maintain std. culture by sub culturing on the regular time interval.
Preparation of slant, airstrips, agar plates etc.
Disposal of contaminated media after proper inactivate cycle of autoclave.
Conduct cleaning validation of reactor using swabs, contact slides and rinse samples of manufacturing equipment according to protocol.
Purified water sampling and testing for bioburden/ pathogen
Environment monitoring of class A,B ,C and controlled area by settling plate, air sampling, surface count, gowning count, fingure tip count and particle count.
Performing sterility testing of sterile water for injection ampoules and vaccines by traditional membrane filter technique using manifold to manage multiple samples.
Extensively involved in sterile filing process validation by media fills or products simulation runs to quality sterile manufacturing lines.
Testing of water for endotoxin content by LAL (gel clot method) test
Equipment Operation and calibration- Incubators, pH meter, Dry heat sterilizer, Balance, KF titrator, Steam sterilizer ,Laminar air flow bench (LAF) & Manifold membrane filtration unit.
TRANING:
Certified for clean room setting by PSG group.
Obtained training for ELISA test
COMPUTER SKILL :
Microsoft word, Microsoft Excel and Power point.
Manage media, chemical & reagent inventory by CISPRO (chemical inventory system)
Entering results into the database and making presentable graph, charts and results trends
Basic knowledge to enter result into LIMS programme.
Contact this candidate