Kris May Lyn Coles
Regulatory Specialist II at Flexicare (Group) Limited- Claim this Profile
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Bio
Experience
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Flexicare (Group) Limited
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United Kingdom
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Medical Equipment Manufacturing
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100 - 200 Employee
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Regulatory Specialist II
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Dec 2022 - Present
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Regulatory Specialist
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Sep 2021 - Present
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We Serve Generics Pharmacy
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Davao, Davao Region, Philippines
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Pharmacist Supervisor, Regulatory Affairs
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Jul 2014 - Feb 2020
Processes over-all legal requirements of the drugstore and activities such as application and renewal of all documents (LTO, FDA, Business Permit, Mayors Permit, license and Sanitary Permit. Ensures that company is compliant with existing laws and memorandum imposed by the Food and Drug Administration of the Philippines Ensures that all documents are renewed before the expiry Transacts with the FDA Quimpo Boulevard, Davao City Attends Seminars as a company representative Processes over-all legal requirements of the drugstore and activities such as application and renewal of all documents (LTO, FDA, Business Permit, Mayors Permit, license and Sanitary Permit. Ensures that company is compliant with existing laws and memorandum imposed by the Food and Drug Administration of the Philippines Ensures that all documents are renewed before the expiry Transacts with the FDA Quimpo Boulevard, Davao City Attends Seminars as a company representative
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University of the Immaculate Conception
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Philippines
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Education Administration Programs
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100 - 200 Employee
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Assistant Instructor I
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Jun 2014 - Oct 2017
Manufacturing/Industrial Internship Clinical Instructor, Pharmacy Review Group Leader, Pharmacy Board Exam Lecturer, Pharmacy Omicron Club Moderator, Intramurals Coach for Palarong Lahi, Darts, Scrabble, Word Factory, Cultural Dance and Quiz Bowl Teaches the following subjects: *Biopharmaceutics and Pharmacokinetics (Bioavailability & Bioequivalence of Different Dosage Forms, Volume of Distribution, AUC of Drug, Clearance of Drug, Creatinine Clearance, Half-Life of Drugs, First Order, Zero Order, Third Order Kinetics,Michaelis-Menten Kinetics, Line-Weaver Burk Equation) *Quality Control and Assurance I (Drug Assay Lecture and Laboratory: Titration/Volumetric Analysis, Gravimetric Analysis, Dissolution Testing, Disintegation Testing and other dosage forms tests, calculations etc.) *Quality Control and Assurance II (Instrumentation Analysis, Lecture and Laboratory: Drug/Chemical Analysis via UV-Vis, Flame Spectroscopy, GC-MS, HPLC, FTIR, Stability/Shelf-life Testing, t50, t90, Arrhenius Equation,calculations etc.) *General Inorganic Chemistry, Pharmacognosy & Phytochemistry, Pharmacy Jurisprudence and Ethics, Health Ethics, Pharmacy Informatics RESEARCH INVOLVEMENT: Thesis Co-Adviser (2014-2015)– “The Quality of Formulated Banana (Musa cavendishii) Extract Lotion as Hair Grower” Thesis Panelist (2014-2015)– “Effects of Pomelo (Citrus grandis) on the Bioavailability of Metformin in Rabbits” Show less
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Healthweb Medika Co., Ltd.
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Davao, Davao Region, Philippines
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Regulatory Affairs Pharmacist and Admin Assistant
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May 2013 - Mar 2014
Communicates with the Manufacturers regarding the renewal of legal documents needed by the company for the initial/renewal of CPR and initial/renewal/add source in LTO which are the Certificates of Free Sale, Agreement, GMP, ISO9001,ISO 13485 and CE Ensures that all documents are renewed before the expiry Ensures that all data and tests performed on products are correct, valid and compliant with the ISO, BP, IP, and USP Creates and Layouts product brochures indicating product’s features and specifications Transacts with the FDA Sta. Cruz, Manila, and FDA Bajada, Davao City Attends Seminars as a company representative Evaluates the validity and accuracy of the following documents:Free Sale, CE Certificate, cGMP/GMP Certificate, Licence to Operate, Product design specifications (length, color, weight etc.), analytical,technical, & clinical performance specifications (tensile strength, sharpness, limit of detection, accuracy, battery life etc.),Raw Materials Safety Data Sheet (ex. PP,PE, HDPE, LDPE, Stainless Steel, Cellulose fiber, Vinyl, Latex, Nitrile, Nylon, Polypropelene, Silk, Polyester, safety tests (ex. Pyrogen test, Skin test, LAL test, AMES test, Mutagenecity test, cytotoxic test etc.), Sterilization Method, Protocol and Validation (EO, Radiation, Dry Heat, Chemical etc.), Stability Studies (Accelerated and/or Real Time Studies), Risk Assessment , Labelling and Packaging Requirements Responsible for the registration/notification of Syringes, Needles, Sutures, I.V. Catheter with and without Injection Port, Pregnancy Test Kit, Surgical Gloves, Disposable Face Mask, ECG Machine, ECG Electrodes, Specimen Cups, Glucometer, Lancets , Butterfly Syringe, Foley Catheter, Urinary Bag, Colostomy Bags, Skin Tapes, Bandages, Oxygen Mask, Nebulizing Kit Pedia and Adult, I.V. Flow Regulator, Three Way Stopcock with and without Injection Tube, Burette Set, Endotracheal Tubes (plain and cuffed), Guedel Airway, Disposable Skin Stapler, Skin Stapler Remover etc. Show less
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Gamot Publiko Your Generic Drugstore
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1 - 100 Employee
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Pharmacist Supervisor
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Jun 2012 - Feb 2013
Educate and orient/ train staff regarding knowledge in pharmaceutical products Ensure that the all pharmaceutical requirements are properly met. e.g. FDA Reads Prescription, dispenses medication and counsel patients Monitor Inventory and Stock Management including Stock Requesting Maintaining good interpersonal relationship with Local Suppliers Responsible for the Purchasing of New Products that are highly sellable Increase store profit through increase of sales with special promotion on products that are high on profit margin Minimize store loss resulting from expired products and inventory variances Store Budgeting and Cash Management/Liquidation Show less
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Watsons Philippines
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Philippines
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Retail
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700 & Above Employee
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Pharmacist Supervisor
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Apr 2011 - Apr 2012
Supervise over-all pharmacy day-to-day operations (selling, stock management, regulatory compliance, customer service and personnel management. Implement and ensures compliance to all health business initiatives, strategy and program. Processes over-all legal requirements of the drugstore and activities such as application and renewal of all documents (LTO, FDA, Business Permit, Mayors Permit, S3 License and Sanitary Permit. Executes merchandise display techniques that will boost sales and promotes customer satisfaction. Ensures accurate and prompt dispensing of medicines by the pharmacy staff at all times. Reads and interprets all prescriptions and provide medication substitute if needed. Ensures the quality of all dispensed medicines (expiry and monitoring procedures). Ensures adherence of all pharmacy staff to the Company Senior Citizen Act, Company Drug Dispensing Guidelines Provides health and wellness counselling from time to time Monitors and evaluates activities of all pharmacy personnel Cash Vault management Show less
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Education
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San Pedro College - Davao City
Bachelor's degree, Pharmacy -
Davao City National High School
With Honors -
Kapitan Tomas Monteverde Sr. Central Elementary School
With Honors -
University of the Immaculate Conception
Masters of Science, Pharmacy