Quality Assurance Manager with more than 10 years of experience
Resume:
CAREER OBJECTIVE To obtain suitable position in a dynamic work environment which
will challenge my problem solving skills gained through my work experience and allow me to continue develop my knowledge and potential.
EDUCATION Bachelor of Science in Chemical Engineering Technological Institute of the Philippines (TIP)
Quezon City Year Graduated, 2003
QUALIFICATIONS With more than 10 years of progressive experience gained in Pharmaceutical Manufacturing Industry. Areas of expertise include Quality Management, Quality Assurance, Quality Control, Audits, Quality Reviews and Operational Effectiveness.
Extensive experience in quantitative and qualitative analysis and has an in-depth knowledge of analytical instruments including HPLC, GC, FTIR, UV-Vis Spectrophotometer, Dissolution tester, Disintegration Tester, Hardness Tester, Friabilator, Polarimeter, KF Titrator and the likes.
Extensive experience in Analytical Method Development and Validation, Stability Studies and Analysis and Monitoring of Water Systems.
In-depth knowledge in Environmental Monitoring Programs, Sterility Testing, Microbial Limit Tests, Micro Assays, and Good Microbiological Lab Practices
In-depth knowledge in preparation of registration dossiers gained by assisting the Regulatory Affairs Department for the analytical inputs on formulations and actives.
Strong demonstrated knowledge of cGMPs, cGLP, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
CORE COMPETENCIES Close familiarity with the tools, concepts and methodologies of quality management.
Eye for detail – Plans and organizes tactics for improvements at work.
Good team-handling abilities – Possess the ability to interest and convince others when changes are required.
Results-oriented person.
MARICAR ALAMIN GUBALLA
#499 Guevarra St. Cay Pombo, Sta. Maria, Bulacan
Contact Nos.: 093********/091********/044*******
E-mail address: ********@*****.***
PROFESSIONAL Quality Control and Assurance Manager EMPLOYMENT Derm Pharma Inc.
HISTORY Pasay City April 2013 – Present
Act as a focal point and leader to all quality related programs. Direct QA activities to ensure maximum quality and effectiveness.
Guide departments to establish quality standards as per regulatory, industry and market requirement.
Approve or reject the acceptance of starting materials, bulks, intermediates and finished products.
Review and authorize specifications, test procedures and operational procedures.
Review and approve Batch Production Record, monitoring yield reconciliation, Master protocol and summary reports including compatibility study.
Oversee execution of all internal/external corrective actions. Provide leadership to all departments with respect to internal problem solving activities. Maintain and implement internal product and process reporting systems and utilize data driven problem solving techniques to determine root cause/corrective action and promote continuous improvement.
Conduct external audits at the vendor site, vendor rating and their approvals for cost reduction projects.
Handle complaint handling and their redressal, product stability studies and product recall system.
Implement Change/Deviation control procedure by listing out deviations and to implement proper corrective action.
Conduct training classes at all levels; classroom trainings for cGMP, cGLP, cGDP to support all related staff and managers.
Initiate changes and recommend to Plant Operations Manager improvements, cost savings or work simplification
projects/activities ensuring improved performance of the department.
Quality Control Assistant Manager
La Croesus Pharmaceutical Inc.
Biñan, Laguna April 2010 – March 2013
Managed department and overall expectations pertaining to setting accurate schedules, costs and resources.
Ensured delivery against QC department goals and objectives, i.e. Meeting commitments and coordinating overall quality control schedule.
Established and maintained policy for documentation of all products and reviews documentation before is sent out to external customers.
Implemented ongoing quality improvement processes working with interdepartmental teams.
Anticipated program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments.
Managed the planning and execution of product testing efforts, including all associated resources to meet committed delivery dates.
Quality Control Supervisor
La Croesus Pharmaceutical Inc.
Biñan, Laguna Jan 2008 – April 2010
Supervised the operation and activities of the chemical and microbiological section and ensured that only quality materials and products were released for sale on supply.
Checked and released the Certificate of Analysis of raw materials and finished goods.
Oversee Validation of testing procedures and production processes and checked submitted reports of this validation.
Oversee and monitored accelerated and long term stability studies and checked submitted reports of this study.
Reviewed and updated all technical specifications and assay procedures of Raw Materials, In-Process, Bulk and Finished Goods for its correctness and appropriateness as per official or company monographs.
Reviewed Production Batch record (PBR) to assure
completeness and integrity of data entries and on-time endorsement to the Documentation Department for filling and storage.
Responsible in training of the newly hired analyst.
Assisted in maintenance of Quality Systems including Internal Audits, Vendor audits, CAPA, Complaints, and Calibration. Quality Control Analyst
La Croesus Pharmaceutical Inc.
Biñan, Laguna March 2005 – December 2007
Performed quantitative and qualitative analyses on raw materials, in-process samples, bulk and finished products.
Performed chemical analysis using instruments such as GC, HPLC, UV-VIS Spectrophotometer, FTIR, Karl Fischer Moisture Titrator, Dissolution Tester.
Prepared, standardized and maintained records of Volumetric Solutions, Test Solutions, Buffer Solutions, Indicators and Mobile phases used in chemical testing.
Conducted in-house validation of reference standard.
Maintained and calibrated laboratory instruments.
Conducted water analysis.
TRAININGS/ Quality Risk Management
SEMINARS April 2016
ATTENDED
Draft Revision to QMS Requirements - FDIS ISO9001:2015 August 2015
Pharmaceutical Technology
August 2014
Quality Management and Its Ramification Training Series July 15 and 18, 2014
Workshop on Strategic Planning
November 27-28 2013
Workshop on Cleaning Validation
November 2012
International Symposium on Drug Product Quality, Equivalency And Regulations
November 2012
Seminar on Regulatory and Technical Requirements November 2012
16th ASEAN Consultative Committee for Standards and Quality
(ACCSQ) Traditional Medicines and Health Supplements (TMHS) Product Working Group (PWG) Meeting and Related Events November 14-18, 2011
Industry Observer
Comprehensive Seminar on Bioequivalence and Bioassay October 2011
Updates on ASEAN Guidelines for Stability Studies August 2011
Conducting Clinical Trials
July 2011
Life Science/Pharmaceutical Waters
July 2011
Tablet Production
October 2010
Principles of Raw Materials Control
October 2010
Conducting Product Quality Reviews
August 2010
Designing Your Laboratory
April 2010
Microbes in Action: Monitoring, Control and Prevention January 2010
Method Development of HPLC
October 2009
2 day training course held at Singapore
Industrial Hygiene & Good Laboratory Practices
September 2009
Chemical Waste Management
September 2009
Training for Internal Quality Auditor
June 2009
Training/Workshop on Quality Assurance
October 2008
Seminar on Method Validation, Method Development and System Suitability
Training/Workshop on Good Laboratory Practices
October 2008
Training on GC Operation July 2008
3 days hands-on training on how to operate Shimadzu GC 2014 Model.
DIY Your Chrom June 2008
Basic maintenance and troubleshooting of chromatographic systems.
Workshop on Gas Chromatography Aug.-Sept. 2007
3 days instructional seminar and hands-on training on how to operate a Gas Chromatography System.
Workshop on HPLC October 2005
Instructional seminar and hands on training on how to operate the Shimadzu High Performance Liquid Chromatography (HPLC) Prominence System
PERSONAL DETAILS Date of Birth: July 19, 1977
Marital Status: Single
Gender: Female
REFERENCES Ardee J. Doromal
Plant Operations Manager
Derm Pharma Inc.
Zenaida E. Esguerra
Production Manager
Blaine Incorporated
Nicanora A. Padilla
Assistant Vice-President, Production
La Croesus Pharma Inc.
Ma. Luisa A. Battung
QA Manager
ADP Pharma
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