Quality Assurance Analyst

MARY CHRISTAL M. HERNANDEZ

*** ***** **. *********** ****

.mobile: +639*********.

. E-MAIL:*********.********@*****.*** .

CAREER OBJECTIVE

To be employed in a stable company where I can practice my profession,

apply and enhance my knowledge and eventually be an asset to the

company; where there is career growth and job security.

QUALIFICATION

. Pharmacy Board Passer, July 2008

Registered Pharmacist, Registration No. 55430

PROFESSIONAL EXPERIENCE

GlaxoSmithKline

QC Analyst II (Present)

Duties and Responsibilities:

. Practice full compliance to policies related to ESH and 6S, house

rules, current Good Manufacturing Practice, Good Laboratory

Practice, Standard Operating Procedures

. Contribute to the promotion of quality through establishing the

identity and potency of starting/raw materials and drug products

during testing process

. Document all test results in an accurate and timely manner with

corresponding analysis and evaluation

. Operate instruments following approved operating procedure, conduct

verification test as per defined frequency and perform

troubleshooting as needed

. Perform other functions that may be assigned by immediate

supervisor from time to time

ASIAN ANTIBIOTICS, INC.

Top performer: year 2009, 2011, 2012, 2013

Perfect attendance awardees: year 2011, 2012, 2013

Duties and Responsibilities:

As Documents Control Committee Member

>Ensure appropriate distribution of company documents

>Ensure SOPs, test procedures and other documents are reviewed and

updated as needed

QA Laboratory Analyst (November 2008- April 2014)

Duties and Responsibilities (Analytical and Microbiological):

. Provide support to QA Department Head to facilitate efficient

operations within area of responsibility and provide valuable

inputs to ensure departmental Key Result Areas are met

. Practice full compliance to house rules, current Good Manufacturing

Practice, Good Laboratory Practice, Standard Operating Procedures

and policies related to the Integrated Management System

. Plan for the daily workload and ensure materials for testing are

available

. Check raw data, accuracy of calculations and completeness of

laboratory reports

. Ensure compliance to lead time in testing and documentation of test

results

. Review SOPs, work instructions and test procedures and update as

necessary

. Ensure laboratory out of specifications and laboratory deviations

are investigated in a timely manner and appropriate

corrective/preventive actions are done, where necessary, to prevent

recurrence

. Monitor compliance to calibration and preventive maintenance

schedule of laboratory equipment to ensure these are in good

working condition

. Ensure accurate inventory of laboratory supplies

. Ensure records are labeled for traceability, properly maintained

and retained

. Provide training for laboratory personnel on House Rules, GMP, GLP,

SOP and instrument operating procedures

. Monitor and report performance of the laboratory on a monthly basis

. Prepare protocol for analytical test method transfer

. Contribute to the promotion of quality through establishing the

identity and potency of starting/raw materials and drug products

during testing process

. Perform laboratory and microbiological testing of samples following

established analytical/test procedures

. Document all test results in an accurate and timely manner with

corresponding analysis and evaluation

. Complete assigned validation, qualification and verification

activities within set timelines in accordance to approved protocol

and with corresponding analysis of trends

. Operate instruments following approved operating procedure, conduct

verification test as per defined frequency and perform

troubleshooting as needed

. Review and update Standard Operating Procedures and Test Procedures

periodically

. Perform other functions that may be assigned by immediate

supervisor from time to time

QA Operations Analyst (August 2008 - November 2008)

Duties and Responsibilities (Stability and Products Section):

. Allocation and monitoring of local and imported stability samples

and evaluation of stability performance of the product

. Prepare Stability Reports for renewal of Certificate of Product

Registration

. Assist in product stability related technical issues

. Allocation for laboratory testing and evaluation of results for

imported finished goods

. Inspection of Physician Sample and Imported Finished Bulk

. Inspection of finished goods with non-conformities

SEMINARS AND TRAININGS ATTENDED

Internal

. Current Good Manufacturing Practices

. Safety Orientation

. Hazards Identification, Risk Assessment and Determining Controls

. Good Laboratory Practices

. Lean Manufacturing

. Equipment Cleaning Validation

. Statistical Process Control

. Pharmacovigilance Training on Adverse Drug Reaction/Event Reporting

SOP in Unilab

External

. Pest Awareness (Rentokil)

. Basic Life Support (Philippine National Red Cross)

. Globally Harmonized System of Classification & Labelling of Chemicals

& Suitability Study for Drug Binding Assay (Yana Chemodities)

. Pharmacopeia Update Forum: Improving Lab Productivity (Guill- Bern

Corporation, Intercontinental Hotel)

. 7th Annual Pharmaceutical Analysis Forum (Perkin Elmer, New World

Renaissance Hotel)

. Life Science/ Pharmaceutical Water Systems (ISPE, Crowne Plaza)

. Microbes in Commodities and GMP (Yana Chemodities)

. Lab Solutions from Merck Millipore (Merck)

. Dissolution Testing And Handling of Raw Materials (ISPE, Crowne Plaza)

. Bacterial Endotoxin Test (Lonza, Richmonde Hotel)

EDUCATION

University of Santo Tomas

BS Pharmacy, 2008

INTERNSHIP

Mercury Drug- Boni Pinatubo Branch

Our Lady of Lourdes Hospital

World Citi Medical Center

United Laboratories, Inc. (Quality Assurance-Packaging Materials Section)

PERSONAL INFROMATION

Born on July 23, 1986; Female; Filipino; Roman Catholic

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