Ma Isabel Grace Martinez

RESUME Ma Isabel Grace Q. Martinez Residence Permit: Y08XFH0VF Austrasse 9 Oberursel 61440 Germany Tel No.:-- Personal Data Date of Birth November 5, 1973 Place of Birth Gender Mandaluyong, Metro Manila Female Civil Status Married Nationality Filipino Summary of Qualifications Apr 2016 – June 2017 Analytical Chemist III, AS&T Novartis Singapore Pharmaceutical Manufacturing Singapore Sep 2009 – Apr 2011 Analytical Chemist Novartis Singapore Pharmaceutical Manufacturing Singapore Nov 2007 – 2009 Chemist (QC Leader) Beacons Pharmaceuticals Pte. Ltd. Singapore Nov 2005 –Nov 2007 QA/QC Supervisor Biomedia Pharma Pte. Ltd Singapore July- Quality Control Chemist Malaysia Chemist Pte. Ltd. Singapore 1997 – 1998 Group Supervisor Golay Buchel Phils, Inc Philippines 1995 – 1997 Laboratory Analyst Cosmos Bottling Corporation Philippines Work Experience April 2016 – June 2017 Novartis Singapore Pharmaceutical Manufacturing Analytical Chemist III, Analytical Support Team (AS&T) • • • • • • • • • Support the introduction and use of new analytical technologies and IT systems (SAP, Chromeleon CDS, Paperless Lab/LIMS) within the QC group Support the MS&T Department in the areas of continuous process verification, continuous improvements, PAT and Quality-by-design principles Leading and support equipment purchases, initial qualification and on-going PM/PQ activities Certified investigator to lead and support QC laboratories in complex deviations investigation Leading analytical method transfers and verifications for drug products, API´s and excipients Overseeing and coordinating method transfers associated with new product launches/manufacture Preparing, reviewing and approving gap assessments for Novartis QM/QDs and Pharmacopoeia changes Preparing and reviewing QC relevant APR/PQR sub-reports Provide training to new AS&T associate May 2013 – Mar 2016 Novartis Singapore Pharmaceutical Manufacturing Analytical Chemist III, Drug Product Laboratory (DP Lab) • • • • • • • • Techincal leadership and development of team/QC members Initiate investigations/Deviations and support the investigator in the laboratory investigations/Deviation Non-routine analytical testing and support to routine testing Execute method transfer/validation/verification Completion and reviewing of GMP documentation Raw data/Test results review Equipment owner/System super user (SAP/CSV system) Creation/revision of SOPs/work instructions /forms/technical protocol and report review May 2011 – April 2013 Novartis Singapore Pharmaceutical Manufacturing Analytical Chemist II, Drug Product Laboratory (DP Lab) September 2009 – April 2011 Novartis Singapore Pharmaceutical Manufacturing Analytical Chemist I, Drug Product Laboratory (DP Lab) November 2007 – 2009 Beacons Pharmaceuticals Pte. Ltd. Singapore QC Chemist (QC Leader) • • • • • Performs method validation and method verification of the current analytical procedure Assist the Total Quality Manager in supervising the Quality Control Department Ensures that all QC reports have been reviewed in accordance to the approved QC procedures and protocols Ensures that all products are released based on the approved product specifications Ensures that all equipments are calibrated and working in most favorable condition • • Assist in the preparation of protocols relevant to Quality Control Ensures that all samples have been delegated to QC Analyst and tested in accordance to the specified analytical procedure November 2005 – Nov.2007 Biomedia Pharma Pte. Ltd. QA/QC Supervisor • • • • • • • • • • • • Overall in-charge of all the operations in the Quality Control laboratory, in-process control and GMP implementation concerning products quality and quality control department Assist in the preparation for SOPs (Standard Operating Procedures) for the quality control department. Assist the pharmacist in preparing the protocol for the validation, stability testing and and developing and validating analytical method and testing of new product formulations Ensuring that all tests performed are in accordance with the correct approved methods. Responsible for delegating QC technicians to inspect and perform sampling for raw materials and packaging materials as well as to conduct in-process QC during operation. Assist the pharmacist to conduct GMP training to production personnel and subordinates. Evaluate pharmaceutical technical complaints and production failure together with the pharmacist and production manager. Responsible for conducting, evaluating and summarizing analytical method validation, conducting and evaluating cleaning validation and stability studies. To approve specifications, sampling instructions, test methods and other quality control procedures. To check and maintain all the equipment in the quality control laboratory, ensuring that all critical measuring equipments are calibrated regularly in accordance to the calibration programme Assist the pharmacist in qualifying suppliers of raw materials and all other starting materials, ensuring that the materials received conform to established specifications. Responsible for assuring that the drug manufactured complies to the established requirements as per drug registration and meet with the established specifications set by the company. The QC department is responsible for the releasing and rejecting of all starting materials, printed materials, packaging materials and finished products in accordance to established procedures and specifications. July 2002 – Present Malaysia Chemist Pte. Ltd. Quality Control Chemist • • • • • • • • • • • • • Singapore Singapore Performs method validation of the current/existing analytical procedure Proficient in handling various equipments such as, HPLC, uv-vis spectrophotometer & FTIR Performs routine analysis of the raw materials, in-process samples, finished products and stability samples based on USP / BP or manufacturer’s method Prepares and standardize reagents & laboratory solutions needed for the analysis Monitors and maintain chemical stocks and inventories Performs calibration of the equipments such as pH meter, weighing scale as well as checking of the wavelength accuracy of the spectrophotometer Ensures that the quality of the product is within specification and control Ensures that every action complies to Good Manufacturing Practice Oversee the process and activities within QC Department Ensure that all equipments used for analysis are calibrated and performing in optimum condition Ensure that all the products released for distribution are within the specification and control Ensure that every action complies to Good Manufacturing Practice Monitors and maintain chemical stocks and inventories 1997 – 1998 Golay Buchel Phils, Inc. Group Supervisor • • • • • • • • • • Sta. Rosa Techno Park Orients and trains newly hired personnel (directly involved in Sorting personnel) Supervises Sorting personnel. Reports to Concerned Group Head the status and performances of Sorting personnel. Maintains and monitors qualified processes. Ensures that the quality of the product is within specification and control Ensures the appropriate set up of machines and equipment in accordance with Reference Standard. Maintains and updates record in the Process Control Sheet against the order schedule plan and quality plan. Ensures tags and labels on corresponding lot number and order number as against the Product Identification and Traceability in preparation for issuance in the next process. Receives request for traceability from the Concerned Group Head. Reviews the NCP (non-conforming product) for disposition and ensures that all labels and tags for the NCP are accomplished in accordance with the Product Identification and Traceability. 1995 – 1997 Cosmos Bottling Corporation Laboratory Analyst San Pedro, Laguna Water Treatment Laboratory • • • Performs boiler / cooling water analysis. Informs Power plant supervisor to conduct blow down if defects were detected. Prepares necessary chemicals needed in all analyses. Bottled Water Laboratory • • Analyze according to sampling plan starting from raw water source to the processed bottled water of it’s parameters such as Iron, Hardness, Silica content, Conductivity etc., in order to attain quality product. Checks processed bottled water for any discrepancy in order to do necessary actions if needed. Raw Material Testing • • • • Supervises in syrup preparation. Analyze all incoming raw materials. Tests the quality of water as well as beverages produced. Analyzes the causticity used in bottled washing. Education- National University of Singapore Graduate Diploma in Analytical Chemistry Singapore 1989 – 1994 Mapua Institute of Technology B.S. Chemical Engineering Philippines 1985 – 1989 Colegio de Sta. Catalina de Sena Secondary School Philippines 1979 – 1985 Colegio de San Pedro Primary School Philippines Trainings and Seminars Attended Pharmaceutical & Compliance Seminar July 2013 Agilent Technologies, Singapore Agilent Practical GC August 2012 Agilent Technologies, Singapore Agilent LC Maintenance & troubleshooting June 2011 Agilent Technologies, Singapore Microsoft Excel 2007 Intermediate July 2010 Informatics Centre, Singapore Method Validation October 2003 Agilent Technologies, Singapore Microsoft Office 98 June 2000 Informatics, Singapore Environmental Awareness September 1993 UP Diliman, Philippines Basic Water Chemistry February 1996 Asia Brewery, Philippines Ion Exchange Water Treatment August 1996 Asia Brewery, Philippines Cooling /Boiler Water treatment June 1996 Asia Brewery, Philippines Trainer’s Training Seminar August 1997 Golay Buchel Phils., Inc., Philippines Good Housekeeping (5S) November 1997 Golay Buchel Phils., Inc., Philippines ISO 9002 Awareness Seminar November 1997 Golay Buchel Phils., Inc., Philippines Quality System Seminar November 1997 ISO Support Document and Dev’t. November 1997 Golay Buchel Phils., Inc., Philippines References Golay Buchel Phils., Inc., Philippines Will be provided upon request I hereby certify all the information in this application as true and correct to the best of my knowledge. Ma. Isabel Grace Q. Martinez 25 Aug 2018