Register Pharmacist with in-depth knowledge in Quality Assurance Opera
Resume:
EMELYN DIOSO BERNASOR
***********@*****.***
**** ****** **. ********** ****. Brgy. Pag-asa Binangonan, Rizal
Philippines
PROFILE
Dedicated and hardworking Pharmacist with more than 18 years of experience in Pharmaceutical Industry. Experience in quality control laboratory settings and able to operate Dissolution Test and HPLC. Also, with an in-depth knowledge in the process of medicine as well as Current Good Manufacturing Practice and the regulatory requirements set by FDA and based on PIC/s. Also, have a on-going experience in Retail setting (Pharmacy) ensuring that the store is also compliant with FDA regulatory and conducts patient counseling if needed.
SKILLS
Pharmaceutical Knowledge
Leadership
Teamwork
Time Management
Communication
KNOWLEDGEABLE
SAP System
Coupa System
LIMs
Minitab
Dissolution Tester
HPLC
Stability Chamber
WORK EXPERIENCE
Quick Relief Pharmacy
Pharmacist
August 2024 to Present
Check the expiry date, DR No. and Lot. No. of the product upon receiving drug from the Supplier.
Fill prescriptions and dispense drug properly when available in the pharmacy.
Check the lot no. expiry dates and label of drugs before dispensing to the customer.
Responsible for monitoring the availability of the drugs
Provide drug information to the customer.
Ensure the proper storage and handling of drugs and medical devices
The one who writes in the Prescription Book.
WORK EXPERIENCE
Amherst Laboratories Inc.
Supervisor
Quality Assurance Operations
November 2022 to April 2024
Planning, development, and maintenance of efficient Quality Assurance Operations Systems, Line QA, Document and Data Control and Quality Assurance Validation
Set Line QA, Validation and Document and Data Control’s goal, objective and strategies to meet Company’s quality requirement.
Release Finished Goods in SAP system.
Ensures that all released Finished Goods are compliant with FDA regulations.
Provide support in Validation Team.
Perform purchase requisition using Coupa System.
Assess and prepare the annual budget for the team.
Assess and evaluate team’s performance.
Group Leader
Quality Assurance Operations
August 2019 to November 2022
Planning, development and maintenance of efficient Quality Assurance Operations System, Document and Data Control and Quality Assurance Products.
Set Line QA and Document and Data Control’s goal, objective and strategies to meet Company’s quality requirement.
Release Finished Goods in SAP system based on conforming results.
Ensure that the Production follows the current Good Manufacturing Practices and compliant with FDA regulations.
Ensure that batch documents used by Productions are controlled by Document and Data Control unit.
Ensure that the Certificate of Analysis is available upon request.
Liquids QA OIC .
Quality Assurance Operations
August 2018 – August 2019
Set the QA Materials, QA Stability and Product Quality Review’s goal, objective and strategies to meet Company’s quality requirement.
Provide support to Technical Services Unit in the resolution of technical problems.
Release starting and packaging materials in SAP system based on conforming results and compliant with FDA regulations.
Review and evaluate the effectiveness of the CAPA generated by the Supplier in Quality Notification portal.
Monitor and evaluate stability results.
Ensure that the schedule of Product Quality Review report is meet.
Unit Leader - Product Quality Review
Quality Assurance Operations
January 2012 – August 2018
Prepares / Reviews Product Quality Review report with recommendations like further process review, revalidation and/or change in process specification.
Monitors results of in-process test and laboratory tests and coordinate with Technical Services for possible process improvement.
Conduct monthly meeting with Production, Technical Services, Quality Control Laboratory and Client Representative to discuss findings of review and necessary action plan.
Monitor the performance of the Product Quality Review (PQR) Team.
Act as Subject Matter Expert during meetings, external audit and potential client visits.
Reviews encoded data of routine products.
Trains product quality review encoder on data encoding.
Trains other on procedure on conducting product quality review.
Conduct monthly self-inspection and 6s audit in Quality Assurance Department to ensure the team's compliance to cGMP and Operational Excellence.
WORK EXPERIENCE
Amherst Laboratories Inc
Analyst - Line QA
Quality Assurance Operations (Line QA)
August 2009 – December 2011
Ensures cGMP implementation of Production by stringent line monitoring to ensure that critical parameters and critical attributes are in conformance to specifications.
Inspects, samples and provides disposition (Approves/Rejects) on in-process test and finished goods.
Ensures that Good Documentation Practice is implemented on all evaluated batch documents.
Ensures necessary testing is carried out and results complied with specifications.
Performs relevant system transaction (SAP) to document the disposition of the product.
Prepares / Reviews Standard Operating Procedures.
Generate certificates of analysis on finished products as needed.
Generika Drugstore
Pharmacist
March 2009 – July 2009
Check the expiry date, DR No. and Lot. No. of the product upon receiving from the distributor/ company.
Fill prescriptions and dispense drug properly when available in the pharmacy.
Check the lot no. expiry dates and label of drugs before dispensing to the public.
Responsible for monitoring the availability of the drugs
Provide drug information to the public
Ensure the proper storage and handling of drugs and medical devices
The one who writes in the Prescription Book and Dangerous Drug Book.
Hizon Laboratories Inc.
Pharmacist in Charge
March 2007 – January 2009
Prepares the work schedule of the production personnel in granulation, compression, encapsulation and coating areas based on the schedule given by Manufacturing
Coordinator as well as to secure Manufacturing Order / Manufacturing Procedure of the products.
Coordinates with the PIC dispensing regarding the release and transfer of dispensed raw materials from dispensed area to granulation and coating area.
Check and clear the area (granulation, compression, encapsulation and coating) before the start of every operation. Checking includes the cleanliness of the areas and equipment to be used in the operation and operator’s compliance to CGMP on personnel grooming.
Constant monitoring of the granulation, compression, encapsulation and coating operation.
Enforces strict adherence to the manufacturing procedures and controls as required by the FDA regulatory.
Report any machine breakdown to the Manufacturing Coordinator for proper disposition and informed Engineering Department to repair the equipment.
Prepares reports through accomplished forms, these were Manufacturing Order and Manufacturing Procedure.
Evaluate personnel performances and work attitudes and report these to the Manufacturing Coordinator.
WORK EXPERIENCE
General Drug and Chemical Company
Quality Control Analyst
September 2005- December 2006
Performed routine and stability analytical test for food and drug products from in-process finished goods (syrup, liquid, capsules, tablets and suppositories).
Performed dissolution test using Hanson Research Dissolution Tester.
Knowledgeable and experienced to operate some instrument like manual and latest HPLC, UV / VIS Spectrometer Lambda 25 and 2S and Hanson Research Dissolution Tester.
Helps in the implementation of ISO 9001 2000 Standards in quality control related activities and function of the department.
Support BFAD and DENR regulation of the company.
REFERENCES
Amerie Cleo Capili Grace Arcega
QAO Assistant Manager Manufacturing Officer
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