1. CHRISTINE MARIE C. GARCIA
Address: Blk 143 Rivervale Drive #07-559 Singapore 540143
Mobile No. +65 98860274
E-mail: garciachristinemarie@yahoo.com
Licensed Pharmacist: Professional Regulation Commission, Philippines
Registration No.: 0058606
PERSONAL INFORMATION
Birth Date: December 15, 1989
Language (Written/Spoken): English, Filipino (Tagalog)
WORK EXPERIENCE
August 2010 – May 2016
Pascual Laboratories Inc. (PLI)
Km. 31, McArthur Highway, Balagtas, Bulacan, Philippines 3016
Tel. No.: +63 44 693 1891-95
Technical Assurance Specialist
(August 2014 – May 2016)
 Tracks the progress of product batches with technical/quality issues and
provides regular updates to the Plant Technical Committee,
 Facilitates the drafting and execution of Reworking Procedures to
salvage products with technical/quality issues and monitors the progress
until final disposition,
 Oversees the compounding of products with reported technical/quality
issues, initiates process improvements, changes, or other interventions to
resolve the issue,
 Monitors trial batches with modifications in the manufacturing process,
 Conducts technical investigation through review of related documents
and literature and in coordination with concerned departments and
personnel. The investigation encompasses review of product
formulation, manufacturing process and parameters, analytical results,
product trending, stability data, batch documents and other relevant
technical data/information,
 Designs and initiates verification studies / procedures / protocols relevant
to products identified needing process improvement,
 Facilitates technical review and endorsement to Product Development
Team for products with recurring issues needing formulation review and
improvement, and
 Prepares the following relevant documents as needed:
- Verification Protocol
- Verification Report
- Endorsement Report
- Validation Documentation
Related Activities:
 Conducts process validation and prepares the relevant validation
documentation for existing products to ensure consistent and
reproducible manufacture of finished products in accordance with
established specifications,
 Provides technical support in Cleaning Validation as needed,
 Handles special projects related to Technical Assurance which may be
needed from time to time

2. Cleaning Validation Officer
(June 2011 – July 2014)
 Conducts trial and monitoring causing variability on the characteristic of
in-process material and the drug product
 Prepares Risk Assessment matrix for selection of worst-case cleaning
procedure/ equipment, selection of worst-case product, prioritization of
worst-case cleaning validation studies;
 Prepares Gantt Chart/ Cleaning Validation schedule for three years based
on risk assessment matrix for prioritization of worst-case cleaning
validation program schedule and production schedule forecast
 Prepares validation procedure/ protocol for cleaning procedure of
equipment in order to have a consistent and reproducible manufacture of
finished products in accordance with established specifications,
 Conducts cleaning validation,
 Conducts revalidation of cleaning procedures whenever there are new
equipment or product and any changes in the list of product runs in the
equipment or other changes that may affect the risk assessment matrices
for cleaning validation
 Prepares the following relevant documents as needed:
- Cleaning Validation Protocol and Report
Related Activities:
 Prepares validation procedure/ protocol for new or old equipment and
process in order to have a consistent and reproducible manufacture of
finished products in accordance with established specifications,
 Conducts equipment and process validation,
 Conducts revalidation of equipment, and process whenever there are
changes made that affects product quality
 Prepares the following relevant documents as needed:
- Equipment Validation Protocol and Report
- Process Validation Protocol and Report
 Provides regular updates of product batches with technical/quality issues
to the Plant Technical Committee,
 Oversees the compounding to packaging of products with reported
technical/quality issues, initiates process improvements, changes, or
other interventions to resolve the issue,
 Monitors trial batches with modifications in the manufacturing process,
 Witness in Research and Development Pilot Batch Validation
 Designs and initiates verification studies / procedures / protocols relevant
to products identified needing process improvement,
 Assists in technical review and endorsement to Research and
Development (R&D) Team for products with recurring issues needing
formulation review and improvement
QA Validation Officer
(February 2011 – June 2011)
 Conducts equipment, facilities, utilities, cleaning and process validation
 Conducts revalidation of equipment, facilities, utilities, cleaning and
process whenever there are changes made that affects product quality
 Prepares the following relevant documents as needed:
- Equipment Validation Protocol and Report
- Facilities Validation Protocol and Report
- Utilities Validation Protocol and Report
- Cleaning Validation Protocol and Report
- Process Validation Protocol and Report

3.  Executes annual environmental monitoring (air particulate count, air
flow verification and thermal mapping)
 Prepares Process, Equipment and Facilities Validation Report of
validated product/ equipment/ facility
 Conducts rated capacity monitoring on the different production machines
per product run and other actual validation as requested by other
department in order to ensure the capability of the equipment to produce
quality products
 Reviews and revises Standard Operating Procedures, and Protocols
 Conducts trial and monitoring causing variability on the characteristic of
in-process material and the drug product
 Monitors trial batches with modifications in the manufacturing process,
 Conducts technical investigation through review of related documents
and literature and in coordination with concerned departments and
personnel. The investigation encompasses review of product
formulation, manufacturing process and parameters, analytical results,
product trending, stability data, batch documents and other relevant
technical data/information,
 Designs and initiates verification studies / procedures / protocols relevant
to products identified needing process improvement,
 Facilitates technical review and endorsement to Product Development
Team for products with recurring issues needing formulation review and
improvement, and
 Prepares the following relevant documents as needed:
- Verification Protocol and Report
- Endorsement Report
- Validation Documentation
Records, Review and Release Asst.
(October 2010 – February 2011)
 Receives and checks Batch Production Records
 Timely evaluates Batch Production Records for its accuracy and
completeness of data prior to release of its finished goods;
 Receives and checks Retention Samples
 Follow-up Retention Samples and Product Specifications/ Results of
those products for releasing
 Close monitoring of product status scheduled for delivery especially for
urgent deliveries
 Updates Retention Sample Room Temperature and Relative Humidity
Monitoring
 Maintains and safe keeps Batch Production Records within the
prescribed period of time in order to ensure that readily available
documents for reference purposes or any case that may arise
 Maintains and safe keeps Retention Samples within the prescribed period
of time in order to ensure that readily available samples for reference
purposes or any case that may arise
Packaging Documentation Asst.
(August 2010 – October 2010)
 Prepares and ensures effective filing and maintenance of master files of
packaging related documents of existing products
 Checks artworks of both new and revised packaging materials and
maintains packaging related data information on the computer database.
 Revises master packaging documents, packaging material specifications
and procedures

4. QUALIFICATION AND TRAINING ATTENDED
Colorcon Seminar
- Crowne Plaza Manila, Philippines (March 10, 2015)
Getinge Sterile Process System for Life Science and Pharmaceutical Industries
- Research Institute for Tropical Medicine, Filinvest Comp., Alabang, Muntinupa City,
Philippines (September 29, 2014)
Introduction to PIC/S GMP
- September 8, 2014, PLI Plant Auditorium, Balagtas, Bulacan
FESTO Automation Dialogue on Compressed Air Preparation
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (August 28, 2014)
Validation Training and SOP Cascade
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (July 9, 2014)
Colorcon Training
- PLI Board Room, Balagtas, Bulacan, Philippines (March 20, 2014)
Operating Principles of Method Development, Validation and Transfer (Part 2)
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (September 17, 2012)
Operating Principles of Method Development, Validation and Transfer (Part 1)
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (July 9, 2012)
Stability Training
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (April 27, 2012)
cGMP Refresher Course
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (October 24, 2011)
Change Control Management
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (October 6, 2011)
Statistical Process Control: A Tool for Quality Control
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (September 26, October 3, 2011)
Pharmacovigilance Training
- PLI Plant Auditorium, Balagtas, Bulacan, Philippines (March 08, 2011)
AWARDS AND ACHIEVEMENTS
Gawad Natatanging Kawani August 2, 2013
(Model Employee) (2012 – 2013) PLI Plant, Balagtas, Bulacan
Dangal ng Pascual 2nd
Place Awardee August 2, 2013
(Honorable Model Employee) PLI Plant, Balagtas, Bulacan
(2012 – 2013)
INTERNSHIP
MAJOR
Meycauayan Doctors Hospital (May 2009 – October 2009)
Km. 18 Banga, Meycauayan, Bulacan, Philippines
MINOR
Pharmatechnica Laboratory, Inc. (March 2009 – April 2009)
Sto. Cristo, Pulilan, Bulacan, Philippines
Romel Cruz Hospital (March 2008 – April 2008)
Matimbo, Malolos, Bulacan
Manson Drug Corporation (May 2007 – June 2007)
Balagtas, Bulacan, Philippines

5. EDUCATIONAL BACKGROUND
2006 – 2010 Centro Escolar University
Bachelor of Science in Pharmacy
Km. 44 Longos, City of Malolos, Bulacan Philippines
JOB COMPETENCIES
 Knowledge in MS application, e.g. MS Word, MS Excel, MS PowerPoint and in other software
application.
 Good communication skills, through the years in positions with interpersonal relations, improved with a
year conducting validation and technical investigations
 Possesses leadership qualities, with experience in training newly hired validation officers and technical
specialists and overseeing them even after the training
CHARACTER REFERENCES
Mr. Mario Carlo A. Soliven
Director for Quality Assurance and Product Development
Pascual Laboratories, Inc.
Km. 31, McArthur Highway, Balagtas, Bulacan, Philippines
Email: masoliven@pascuallab.com/ mcsoliven@hotmail.com
Tel. No.: +63 44 693 1891-95 local 122
Mobile No.: +63 922 874 7005/ +63 998 965 1250
Ms. Vanna Alyssa M. Yu
Technical Assurance Supervisor
Pascual Laboratories, Inc.
Km. 31, McArthur Highway, Balagtas, Bulacan, Philippines
Email: vanna.alyssa@gmail.com
Tel. No.: +63 44 693 1891-95 local 111
Mobile No.: +63 917 854 8346