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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLEChilton drive Orlando Florida Street Address
Ready to Relocate, Holding a Green cardWork ExperienceSpecialization. (Production Dosage forms)Manufacturing Injectable IV and IM Oral dosages, Tablets, Caplets, Capsules Liquid orals, Topical ointments and creams.Granulation, Direct compression, spray dry granulation, Sugar coating, Film coating.-Sterile Injectable Large volume and small volume. Manufacturing, aseptically washing rubber bungs, glass containers-Sterilization of finished products by terminal sterilization, By micro filtration, by gas sterilization.-Personal training for aseptic technique-Preparation of bulk compounding for sterile filling.-Machine parts sterilization.-AHU for clean micro filtered (HEPA filtered)-Validation of sterilizers (by challenge test)-Sterile Gowning procedure-Sterility testing, pyrogen testing.-Clean rooms environments monitoring.-SOP of aseptic handling (2006 to 2018 Dawa pharmaceuticals.) (2004 to 2006 Kenya sterile supplies)-Trouble shooting HPLC, FTIR UPLC GC FID ICPMS,-Development of sterilization cycle parameters.-Validation of Dry heat sterilization, and steam sterilization-LIMS. Qualification-DIGIQUAL Qualification.-Challenge test to sterilization process.-CDM0-Lean Manufacturing, Six sigmaCroda Inc.Pennsivania from February to May 2024Sr. QC/QA Analyst;My job involved IQ, OQ. And PQ of analytical instruments like.HPLC GC FID, UHPLC, FTIR ICPMS NMR and UV/VIS Spectrophoto meterAnd commissioning laboratoryQC supervisorSEQENS PHARMA SOLUTIONS. NEWBURY PORT MAFrom February 2023 to October2023Company engaged in manufacturing APIMy duties involve:-Supervision /review of analytical reports -routine analysis of finished products samples and in process samples-Performing Stability tests on all products produced in company.-Implementing CGMP.-Validation of analytical methods and production processes.-Practicing GLP-Working in a team for analysis of API by using HPLC(Agilent) for assays, UPLC, FTIR -Analyzing raw materials and finished products-Implementing CGMP-Validating of analytical methods-IR AND FTIR spectroscopy to identify chemical compounds,-UV/VIS Spectroscopy, used for Quantification and for specificity.-HPLC/ UPLC for quantification and specificity-Mass spectroscopy for determination of mass of parent peak of unknown substance,-Deviations from established, standard operating procedures and Validated procedures.-CAPA Corrective actions, Preventive actions.-Root cause analysis, and investigation.-Batch manufacturing records review.-Analytical reports review.Production ManagerValencia Cosmetics LTD NAIROBI, KENYAMay 2018 to January 2023The company is engaged in manufacturing body care, skincare and hair care products.My duties involved:.-Managing production and production Planning-Quality control.-Plant maintenance-Raw materials procurement, and leading sales and marketing team.-Strategic planning, setting up targets for sales and production team.I Initiated and developed hair care products such as hair spray which takes care of growth of hair and also works as an anti-dandruff. This product gained popularity and grew sales revenue. I developed hair binding/styling gel which was well accepted by consumers. The production of this product grew to the extent of 35 % of the total production.--Management of treatment of water by deionization, reverse osmosis and micro filtration since water is an important raw material in our formulationProduction ManagerDawa pharmaceuticals ltd NairobiOctober 2006 to April 2018The company was engaged in production of oral, topical, sterile and injectable dosage forms.My duties involved:-Managing production: planning and execution to meet the production targets.-Raw materials and packaging materials procurement-In process control, administrative control-Implementing CGMP-Validation of production process.-Scheduling Production machines maintenance. and approving SOP.-Monitoring vials, ampules and change parts sterilization, Aseptic processing Manufacturing Sterile injectables.-Documentation of production-Initiating release procedure of the products.-Final overview BMR (Batch Manufacturing Record).-Validation and quantification through HPLC of Simadzu make-Running the plant efficiently. We were never out of stock.Planning of production was on time so company gained sales. -Sterile Injectable Large volume and small volume. Manufacturing, aseptically washing rubber bungs, glass containers-Sterilization of finished products by terminal sterilization, By micro filtration, by gas sterilization.-Personal training for aseptic technique-Preparation of bulk compounding for sterile filling.-Machine parts sterilization.-AHU for clean micro filtered (HEPA filtered)-Validation of sterilizers (by challenge testI started with them doing 5million ksh in sales. When I left, the company was doing 156million in sales per month.Production ManagerKenya sterile supplies Ltd (KSSL)April 2004 to 2006The company is engaged in manufacturing large volume I.V. parenteralI was the technical and administrative head of this plant, monitored all functionsMy duties Involved:-Compounding, filling and sterilization-Overall operation of production-Quality control-Overseeing raw materials and packaging materials procurement-Implementing aseptic technique.-Approving SOPs for operation and maintenance of the plant.-Monitoring sterility testing-Monitoring Pyrogen testing and certifying documents for final product release.-Monitoring water treatment for sterile water by reverse osmosis and micro filtration.-Managing general administration and Implementing CGMP.-Monitoring air handler unit for sterile air flow in aseptic areas.-Monitoring stringent implementation standards and SOP. of Vial washing and Ampoule washing Rubber bung washing and sterilization. Aseptic Processing.I developed a new product Ringer Lactate large volume parenteral 500 ml and Metronidazole IV fluid 100ml. confirmed stability and effectiveness.Manager Quality Assurance/ProductionUltra-food chem. Ltd NairobiAugust 1997 to May 2003The company engaged in manufacture and distribution of nutraceuticals, soft drinks, drinking water, (water treatment by UV, Microfiltration and reverse osmosis) cosmetics and disinfectantsMy duties involved:-Direction and control of the entire quality control system and production functions of the company.-Management of overall strategic planning and supervision-implementation of GMP and maintenance of quality of raw materials and packaging materials.-Overseeing daily operation of quality controls and production.-Conducting research and developing new products.-Designing preventative maintenance and machine servicing schedules.-Managing the general administration of staff relationsThe entire plant was my initiation. I developed soft drinks- aerated and non-aerated of 10 flavors. I also developed domestic cleansers which made company to gain remarkable revenue.Production ManagerPharmaceutical Products Ltd NairobiJuly 1992 to May 1997The company was engaged in manufacturing pharmaceutical products, non-sterile, Oral and topical pharmaceutical dosage forms.My duties Involved:-Managing routine activities of production planning and execution,-Providing assistance to all quality control functions-Inspecting all incoming raw materials and outgoing finished products-Monitoring internal receipt and dispatches of materials.-Managing all marketing functions of pharmaceutical products.-Setting the targets of production and sales team.-Implementing cGMP.Company was doing 2 to 3 million KSH in sales. I strategized the production, so sales increased. The facility was not capable of sustaining production due to the high demand, so we had to buy land and initiate a bigger plant.Production chemist/Production Manager Sterile injectionsLaboratory and Allied Ltd NairobiDecember 1990 to June 1992The company was involved in manufacturing sterile, oral and topical products.My duties Involved:-Managing production planning, raw material procuring for the sterile injectable dosage.-Monitoring quality control and production process.-Supervising, packaging and dispatching of finished goods-Certifying finished products, complying with standards and Implementing CGMP-Monitoring sterilization processes of products and aseptic techniques for operation.-Monitoring air handler unit assuring sterile air flow in aseptic areas.-Monitoring implementation of stringent SOP, of vials, ampules washing and sterilizing.-Periodically performing challenge test on sterility.On commissioning the plant, I lodged small volume parenteral products for the registration. We were given initial permission to produce powder /antibiotics injections and then I started liquid injectable.Quality control chemist/ManagerRegal pharmaceuticals ltd NairobiNovember 1988 to October 1990The company was engaged manufacturing Injectable products and oral pharmaceuticals.My duties Involved:-Analyzing various raw materials, finished products and in process control samples.-Directing quality control function of company, which involves sterility test and pyrogen tests-Monitoring Stability tests on all products produced in company.-Implementing CGMP and validation of analytical methods and production processes, by use of methods developed in house and by USP, BP and IP stated methods.-Using physicochemical method, HPLC, LC, TLC IR FTIR methodsI developed methods of analysis of multi-ingredients liquid oralsQuality Control Chemist/ ManagerElyes chemical Industries Ltd NairobiSeptember 1983 to October 1988-The Company was engaged in manufacturing oral / topical pharmaceutical formulations.My duties Involved:-Maintaining of quality standards for various products such as tablets, capsules, oral dry syrups, liquid orals, ointments and creams.-Controlling and planning production right from selecting raw materials up to final finished products-Analyzing raw materials and finished products-Implementing CGMP-Validating of analytical methods.We had to use physico chemical methods, UV, HPLC, LC, TLC IR FTIR and other instruments.I developed Benzoyl metronidazole suspension and confirmed stability and effectiveness.Research ChemistAlembic Pharmaceuticals Ltd - Vadodara, GujaratAugust 1980 to March 1983The company was involved in manufacturing antibiotics from basic stage, liquid injectable and oral pharmaceutical formulations. The company is largest of its kind in India. I worked under quality assurance director.My duties involved:- Distributing work to junior chemists, training them in analytical work,-Sampling and analyzing, of various antibiotics like Ampicillin, Amoxicillin, Cephalexin, Rifampicin, Streptomycin, Kanamycin, Tetracycline, Erythromycin, Chloramphenicol etc. by using methods stated in USP BP IP and our own developed methods.-Certifying final bulk product and process control.- Monitoring validation of production process and Physicochemical analytical methods, HPLC, LC, TLC. IR FTIR,-Approving SOP of each function in production.I developed production process by using sugarcane juice instead of sugar in fermentation process of penicillin manufacturing. It proved to be cost effective and potency remained the same. This was done on a pilot scale.EducationGraduate in ChemistryM.B. Patel science collegeS. P. UNIVERSITY - Anand, GujaratMay 1975 to June 1980IATF 16949:2016Technical Support-Manufacturing Sterile Products (LVP and SVP injectable IM and IV10+ yearsPlant Management manufacturing Tablets,capsules, Liquid orals, and topical products.10+ years** Documentation, production.Quality Control10+ yearsProduction PlanningQuality Assurance10+ yearsLean Manufacturing8 yearsProduction Management10+ yearsCGMP10+ yearsSKILLS* Fluorescence assay *Continuous improvement * Packaging *Good Manufacturing Practices *Root Cause Analysis *Materials Management *Quality Assurance *Scheduling *Staff Supervision *Training and Development* Instruments Trouble shooting ** Corrective and preventive action (CAPA) **Team Management *Assay Development*Batch Manufacturing Record BMR *Biochemical assay, *Colorimeter assay*ERP Systems *Aseptic technic * Sterility*Pyrogen*Toxicity *. Injectable. *Tablets, *Liquid orals *Topical creams *Ointments, Productivity Improvement Analytical Problem Solving*In vitro assay. *Inventory Management *Lab Management*Lab Operation*Laboratory Information Management system (LIMS) *Method validation*Procurement Logistics *Quality Assurance*Quality control *Quality Inspection *Quality Management*SOP Development, *stability assay *Supply Chain *Vendor Management* **Strategic planning for raw material purchase ** **Production Planning. *Quality inspection* Resource planning*Team Management *Pharmaceuticals manufacturing.Inspection, Vessels, Quantity Surveying, Measurements, .*Instruments; spectrophotometer, Fluor photometer, HPLC, TLC. Polari meter, FTIR. Viscometer, potentiometer, RefractometerLanguages English FluentQ C certificates from BEGECA GermanyPresentQuality control and process validation |
