LOREVE CARIO DALAGON
Blk 57 Lot & Sweden St. Harmony Hills 1
Brgy. Muzon, City of San Jose del Monte, Bulacan
Mobile no. 0926-097-4641
Email Address: [email protected]
OBJECTIVE
Seeking a position as a Microbiologist/Quality Control Analyst utilizing extensive experience and skills in laboratory techniques and equipment usage.
SKILLS
• Highly proficient in the use of key analytical equipment (HPLC, UPLC, UV) and the testing of finished products.
• Experience of working in a GMP environment.
• Good IT skills e.g. Microsoft Office (Word, Excel and PowerPoint).
• Ability to achieve and maintain high standards with meticulous attention to detail.
• Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales.
• Self-motivated with the ability to work proactively using own initiative.
• Hands on approach with a ‘can do’ attitude.
• Committed to learning and development.
WORK EXPERIENCED
Internal Auditor – Enson Laboratories Incorporation
Phoenix Road, Meycauayan, Bulacan
February 11, 2019 – Present
• Perform audit under guidelines, described in the company’s Quality Policy statement, ISO 9001:2015 Standard and existing regulatory bodies.
• Applies the relevant portions of the ISO 9001; 2015 Standards, company standards, FDA and BAI Regulations to internal audit work.
• Selects and applies a range of appropriate operational and management tools and techniques; Applies methods for predicting and forecasting to support managerial decision-making about future actions.
• Manages projects within the internal audit activity or organization effectively; selects and applies a range of appropriate business process analysis tools and technique; uses performance management techniques to monitor and evaluate operational and strategic performance.
• Management, control design and control testing techniques; Applies risk management to internal audit activities; Assists the organizations accepted control framework to internal audit activities as appropriate
Microbiologist / Quality Control Analyst – Enson Laboratories Incorporation
Phoenix Road, Meycauayan, Bulacan
April 11, 2016 – Present
• Assist with the development and writing of SOP’s for microbiology laboratory operations, component bioburden testing, water testing, environmental monitoring, and microbiological equipment operation.
• Perform Microbiological Assay, Microbial Limit Test and Sterility Testing.
• Perform aflatoxin assay.
• Conduct Bacterial Endotoxin Testing.
• Perform growth promotion testing of microbiological media.
• Maintain microbiological cultures.
• Conduct Total Organic Carbon testing for Water Samples.
• Conduct environmental monitoring (viable air, viable surface, non-viable particulate) of new production facility, and maintain the environmental monitoring database and trending program.
• Purchase and maintain inventory of critical laboratory supplies.
• Assist with the coordination of sending samples out to various contract labs for testing.
Support sterilization validation and cleaning validation studies, as appropriate.
JR. ANALYST (Method Validation) – Lloyd Laboratories Inc.
(Level IV – Highly Skilled) FBIC, Tikay, Malolos, Bulacan
May 29, 2015 – April 8, 2016
• Sampling and testing of raw materials, intermediates and finished products using current
pharmacopoeias, any associated ‘wet’ chemistry and instrumental techniques (HPLC, UPLC, UV), as appropriate.
• Preparing Quality reports, including analytical reports (for raw materials and finished products),
Certificates of Analysis (CoA) (for finished products) and stability reports.
• Creating and executing method development and method validation test protocols for finished products and generating the appropriate analytical methods.
• Writing analytical specifications using current pharmacopoeias and reviewing existing analytical
specifications.
• Writing/reviewing Standard Operating Procedures (SOPs).
• Calibrating analytical equipment, as and when required.
• Supporting all QC activities.
• Ensuring that procedures are carried out carefully and accurately to eliminate errors.
• Working with all members of staff to maintain and develop the positive progressive culture within the laboratory.
• Observing and complying with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
• Observing and complying with company Health and Safety Policies.
Observing and complying with company Standard Operating Procedures (SOPs).
Laboratory Technician – Lloyd Laboratories Inc.
(Level III – Skilled) FBIC, Tikay, Malolos, Bulacan
May 29, 2013 – May 29, 2015
• Supports the laboratory in conducting tests for raw materials,, bulk products, semi-finished products and finished products following the official of adopted methods of analysis and generates analytical reports.
• Check conformance if physical test results, identification tests and other limit tests with established specification for all samples received.
• Maintains updated records of retention samples of raw materials, finished products and records of preparation of reagents, diluents and mobile phase.
• Maintains fresh stock of reagents and solutions for analysis as well as records of preparation and standardization of solutions and follow guidelines set for its storage and disposal.
• Adheres to Departmental Standard Operating Procedures and Work Instructions based on cGMP, cGLP and ISO guidelines and complies with proper safety regulations.
• Cleans, Maintains and stores equipment and instruments.
• Assures that substances being tested are disposed of properly and safely.
ACCOMPLISHMENTS
• Established method protocols and validation for the Analysis of finished product such as Vitamin A (Retinol), Atorvastatin 5mg Tablet and Ceftiofur HCl suspension for Injection.
• Established protocols and validation in Bacterial Endotoxin Test for Parenteral Injection Products.
• Pioneer for operating the Portable Total Organic Carbon Analyzer at Enson Laboratories Inc. and established a standard Operating Procedure and routine Analysis for Water for Injection.
• Involved in Parenteral Product Validation.
SEMINAR ATTENDED
• Seminar on Familiarizing Agilent HPLC System on July 22-24, 2014 at Lloyd Executive Lounge.
• Seminar on cGMP, cGLP at Lloyd Executive Lounge on May 2013
• Waters Acquity Ultra Power Liquid Chromatography H-Class and Basic Empower 3 Software Training at by RainPhil Inc. in Cooperation with Waters The Science of What is Possible at Unit 230 Burgundy Corporate Tower 252 Sen. Gil Puyat Avenue. Makati City.
• Good Laboratory Practices at Lloyd Laboratories by Mr.Ashok Sharma on December 2015
• Ultra Power Liquid Chromatography User’s Training on Audit Trail by Agilent Technologies at Lloyd Laboratories Inc. Quality Control Department on December 2015.
• SOP-GP-OOS Shelf life of Laboratory Chemicals and Reagents at Lloyd Laboratories Quality Control Department on January 2016 by Mr. Ashok Sharma
• Laboratory Incident Management by Mr. Ashok Sharma at Lloyd Laboratories Inc. Quality Control Department on January 2016.
• Shimadzu UHPLC Seminar at Library Room, Lloyd Laboratories Inc. on December 16, 2015.
• Training in Bacterial Endotoxin Test by Lonza at Enson Laboratories Inc. on January 22-23, 2018.
• Training in Total Organic Carbon by Mettler Toledo on June 15, 2018.
• Quality Risk-based Management ISO 9001:2015 Seminar at Enson Laboratories Inc. on January 2019.
• Internal Quality Auditor training at Enson Laboratories Inc. on February 2019.
EDUCATIONAL BACKGROUND
Colegio de San Gabriel Arcangel
Bachelor of Science in Biology
Area E, Fatima V, Sapang Palay, San Jose del Monte, Bulacan
S.Y 2009-2013 (G.W.A = 1.6) CUMLAUDE
PERSONAL PROFILE
Age : 26 years old Nationality : Filipino
Gender : Female Civil Status : Single
Birthday : May 17, 1992 Height : 5’1
Birth Place : Bislig, Surigao del Sur Weight : 43 kg
CHARACTER REFERENCES
Anniebeth Ortiz Joan H. Long
Quality Control Supervisor Quality Control Junior Analyst
Lloyd Laboratories Inc. Lloyd Laboratories INc.
#0916-504-1228 / 0923-857-6379 # 0926-672-5208
Jose Edison Valerio
Quality Control Head
Enson Laboratories Inc.
[email protected]
#09205291402
I hereby certify that all information enumerated above are true and correct to the best of my knowledge and belief.
Loreve Dalagon