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pharmacist

Location:
Malabon, National Capital Region, Philippines
Posted:
April 19, 2018

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Resume:

Marilyn G. Sengco

# * *****-***** **., ******* City

Tel #: 373-4673 / mobile#:092********

Email: ac46xk@r.postjobfree.com

WORK EXPERIENCE:

March 2015 – Til Present JANISSA HEALTHCARE PHILS. CORP – Ortigas Center, Pasig City

Regulatory Affair Officer

Prepares and process of the company License to Operate renewal application.

Prepares documents for the renewal of the Certificate of Product registration

Prepares and process application for product exemption.

Prepares and process application for non - rad certificate

Prepares documents requested by the sales team for hospital accreditation.

Continuous updating the company with FDA new policies and guidelines.

Feb. 2014 – Til Present HIGHGATE ENTERPRISES – Binondo, Manila

Regulatory Affair Officer

Handles all documentation requirements and processing at the FDA and Center for Drug Regulation and Research (CDRR) and Center for Devices Regulation, Radiation Health and Research (CDRRHR).

Prepares dossiers for drug product initial registration and renewal (ACTD Format) and cosmetic product notification

Prepares the documents for compliance to Notice of Deficiencies to be submitted at FDA.

Prepares protocol documents needed for compliance to abeyance during annual audit by FDA

Continuous updating the company with FDA new policies and guidelines

March 2013 – Til Present NATURAL FORMULA INTERNATIONAL, INC. – Guiguinto, Bulacan

Regulatory Affair Officer

Prepares and process of the company License to Operate renewal at the Regional Office. (e-LTO)

Prepares protocol documents for the renewal of the Certificate of Product registration (e-registration).

Prepares and process necessary documents for the Amendment of the Certificate of Product Registration (e-registration).

Continuous updating the company with FDA new policies and guidelines

April 2011 – Til present OMM HEALTHCARE PHILIPPINES CORP. – Quezon City

Regulatory Affair Officer

Prepares necessary documents for registration and renewal of LTO.

Prepares protocol documents needed for compliance to abeyance during annual audit by FDA.

Prepares dossiers for medical devices product initial registration and renewal (e-copy registration)

Communicate with our foreign source for the documents required for necessary for compliance to the Notice of Deficiencies with regards to product registration and renewal.

Continuous updating the company with FDA and Center for Devices

Regulation, Radiation Health and Research (CDRRHR) policies and guidelines.

Prepares Batch Distribution Record of the company.

March 2017 – March 2018 MOSBEAU PHILIPPINES, INC. – Makati City

Regulatory Pharmacist

Prepares protocol documents for the renewal of the Certificate of Product registration (e-registration) for food and cosmetics.

Prepares PIF of cosmetic products

Communicate with our foreign source for the documents required for initial and for compliance to the Notice of Deficiencies with regards to product registration and renewal.

Continuous updating the company with FDA new policies and guidelines

Feb. 2016 – Jan. 2017 KOSMETICS TECHNOLOGY –Novaliches, Quezon City

R & D Speciallist

Prepares product samples requested by the Sales Manager.

Develops new product line.

August 2012 – Dec. 2015 KHRIZ PHARMA TRADING INC. – Makati City

Regulatory Pharmacist

Handles all documentation requirements and processing at the FDA and Center for Drug Regulation and Research (CDRR), Center for Cosmetics Regulatory and Research (CCRR), Center for Food Regulatory and Research (CFRR) and Center for Devices Regulation, Radiation Health and Research (CDRRHR).

Prepares protocol documents needed for compliance to abeyance during annual audit by FDA.

Prepares dossiers for drug product initial registration and renewal (ACTD Format), cosmetic products, food supplement products and medical device products.

Coordinates with our source for the documents required for compliance to the Notice of Deficiencies with regards to product registration and renewal.

Prepares the documents for compliance to Notice of Deficiencies to be submitted at FDA.

Continuous updating the company with FDA new policies and guidelines.

Handles all regulatory works for the company such as initial & renewal registration (for LTO & CPR), amendments, batch notifications and other regulatory works required.

August 2010 – Oct. 2013 SUNG SHIM MEDICAL INC. – Taguig City

Company Pharmacist / Regulatory Affair Officer

Handles all documentation requirements and processing at the FDA and Center for Devices Regulation, Radiation Health and Research (CDRRHR).

Prepares dossiers for medical devices product initial registration and renewal (e-copy registration).

Prepares necessary documents to comply with the Notice of Deficiencies with regards to product registration and renewal.

Process registration and renewal of License to Operate at FDA.

Prepares protocol documents needed for compliance to abeyance during annual audit by FDA.

Prepares and timely revision of the Standard Operating Procedure Manual (SOP) and the Site Information File (SIF) of the company.

Process the authentication and amendment of CPRs and LTO.

Continuous update with FDA and BHDT policies and guidelines.

Updates all documents & record stock card for traceability & accountability of the company products.

Prepares and checked the batch production record.

Continuous updating the company with FDA new policies and guidelines.

Oct. 2008 – Mar. 2010 SIGNATURES BY JOEL CRUZ, INC. – Meycauayan, Bulacan

Company Pharmacist / Regulatory Affair Officer / R&D Officer

Assists Plant Operations during scheduled site inspection by FDA and HALAL.

Reviews regularly and initiates the timely revision/publication of the company’s Site Information File.

Assists in cGMP training for plant personnel

Issues raw materials, packaging materials, product specifications and other technical documents required by local or international regulations

Investigates and coordinates with concerned parties in the preparation of corrective and preventive actions and plans for compliance on FDA audit requirements

Prepares dossiers for cosmetic product initial registration and renewal.

Prepares and process application of products for HALAL certification.

Process registration and renewal of License to Operate in BFAD

Prepares protocol documents needed for compliance to abeyance during annual audit by FDA.

Develops new product and establishes MBR for the new product.

Conduct lab batch testing for new products

Ensures prototype integrity to specification throughout the development stage and ensures quality of newly launched and improved products.

Coordinates with Toll Manufacturer on production schedule for existing products and those new product developed

Coordinates with toll manufacturer on the quantity of fragrance to be used and scheduled date for batch production of certain products.

Check if the finished products passed the technical specification

Monitoring of finished goods deliveries based on purchase order

Consolidation and prepares summary report of purchase order and delivery receipt per toll manufacturer

Aug. 2003 – May 2008 KATEENSON INDUSTRIES – Caloocan City

Company Pharmacist / Production Supervisor

Prepare the batch record and supervise the whole production area

In-charge in compounding of nail polish, cologne and other products.

Inspection of finished product passes the required specifications.

Assist in training and orientation of personnel involved in the production

Represents the company in its various transaction with FDA and other government agency that concerns the product of the company

Ensures that GMP (Good Manufacturing Practice) and SOP’s (Standard Operating Procedure) are being implemented

Prepares dossiers for cosmetic products initial registration and renewal.

Process registration and renewal of License to Operate in FDA.

Prepares protocol documents needed for compliance to abeyance during annual audit by FDA.

Sept. 2002 – May 2003 HEALTHDIGIT PHILIPPINES – Roxas Blvd. Malate, Manila

Company Pharmacist

Prepares dossiers for medical devices product for initial registration and renewal.

Process registration and renewal of License to Operate at FDA

Acts as the Executive secretary

Marketing

Jan. 2000 – Oct. 2001 I-MART INTERNATIONAL CORP. – Navotas Branch

Branch Pharmacist

Prepares daily sales report

Inventory and purchase order in the pharmacy section

Updating prescription book and generic menu card

May 1996 – Dec. 1999 BLG DRUGSTORE – Valenzuela City

Branch Pharmacist

Inventory of stocks and purchase order

Updating of prescription book and generic menu card

EDUCATION:

COLLEGE CENTRO ESCOLAR UNIVERSITY

1991 – 1995 Manila

Bachelor of Science – Major in Pharmacy

SECONDARY IMMACULATE CONCEPCION PAROCHIAL SCHOOL

1987 – 1991 Malabon City

INTERMEDIATE IMMACULATE CONCEPCION PAROCHIAL SCHOOL

1981 – 1987 Malabon City

TRAINING / SEMINARS:

April – May 1992 Mercury Drugstore

On the Job Training (Community Pharmacy)

Dec. 1992 – Dec. 1993 Mary Johnston Hospital

On the Job Training (Hospital Pharmacy)

April – June 1993 Doctor’s Pharmaceutical Laboratory

On the Job Training ( Manufacturing Pharmacy)

July – Aug. 2008 Philippine Nuclear Research Institute

Radioisotopes Training Techniques – Medical

PERSONAL DETAILS:

Born on March 4, 1974 in Saigon Vietnam, 44 years of age. Married with 2 kids, 5’1 in height and weighs 115 lbs. Roman Catholic in religion. Knowledge in Microsoft Office 2002 Word and Excel. Hard working, patient, fast learner and very much willing to learn. Knowledge in ACTD format for drug registration, e-registration and e-notification for food and cosmetic products and medical device registration.



Contact this candidate