Quality Assurance Control

JOB TARGET

Quality Control / Quality Assurance

Regulatory Pharmacist

WORK EXPERIENCE

- In charge of communicating and coordinating with Food and Drug Administration regarding any company’s concerns such as application for additional activity, inclusion of suppliers, inclusions of products in license to operate, amendments, follow-ups and other related matters.

- Responsible for leading and managing registration and legal activities compliance with requisites of Food and Drug Administration.

- In-charge of monitoring the status of the existing product of the company.

- In- charge of coordinating with FDA Inspection during the scheduled date of visit in the company.

- Ensure the appropriate licensing, marketing and legal compliance of medical products in order to control the safety and efficacy of products.

- Partner with Business Manager in fast tracking new products launches.

- Combine knowledge of scientific, legal and business issues to ensure products distributed meet the required legislation.

- Advise on and coordinate the approval and registration of medical products within the company’s existing product portfolio, as well future products for registration.

- Develop and write clear arguments and explanation for new product licenses and license renewal.

March 2009 to March 2013

Freelance Pharmacist

- Reviews and prepares documents of product registration of Food, Device and Pharmaceutical Products with Food and Drug Administration.

- Coordinates with government regulatory agencies FDA and DOH (on product registration, LTO application and renewal, batch certification of DIVINE GRACE S. BARROS

1260 St. James Alley, Barangay37, Tondo,

Manila, Philippines

Mobile : 096*-*******

Email add: ***********.*******@*****.***

April 2 2013 to February 2023 REBMANN INC.

finished products), DOH (on PNDF inclusion of products certificate and renewal), IPO (on trademark application and request for patent search), and NDIC (UP Manila) (on request for evidence table as a requirement for PNDF inclusion of products).

- Facilitates timely application / processing of relevant permits (batch Certification of Finished products), license (FDA and DOH license to operate) and documents required by FDA and other relevant regulatory agencies (DOH and IPO).

- Establishes systemic record keeping of all permits, licenses and other registration documents for the purpose of timely application for registration. February 1998 – March 31, 2009 Fullerlife Direct Selling Phils., Inc.(Formerly SARA LEE Direct Selling)

- Ensures timely inspection of incoming RM and PM deliveries and conformances of deliveries to written/approved specifications.

- Prepares necessary inspection reports and distribute copies to all concerned departments.

- Maintains updated standard samples and specifications for QA reference.

- Inspects returned stocks from TPM/Branches and recommends actions to be taken.

- Coordinates with suppliers/TPM and other concern department on quality issues. Documents said issues and action taken as reference for the future.

- Handles packaging evaluation of new and existing products to ensure that these are performed as required.

- Assist in the evaluation and audit of supplier and Third Party Manufacturer to ensure conformance to FULLERLIFE Direct Selling Quality Requirements.

Regulatory Affairs

- Assist in the evaluation Assist in the preparation of protocols/documents needed for

- Registration /submission to BFAD; initial, renewal, amendment.

- Preparation of packaging materials needed for registration to BFAD.

- Responsible for the preparation of documents needed for accreditation of various organizations such as government and private accreditation. Apparel, Premium & Incentive Development

- Evaluation of apparel product sample, apparel packaging,, material deliveries and premium items.

- Preparation of finished goods specifications for promotional & incentive items.

- Discuss QA concerns on promotional/incentive. Monitor inspection/rejection report.

Quality Control Inspector on CFT Packaging Material

- Sampling, testing, inspection & dimensional analysis of packaging material.

- Assistance in conducting package development testing.

- Monthly preparation of QA acceptance level per supplier.

- Maintained updated standard sample, inspection files & specification.

- Preparation of rejection report & dealing with supplier.

- Training of seasonal employees regarding inspection.

- Inspection of returned items from third party manufacturer for proper disposal.

September 1996 to February 1997 Sara Lee Philippines, Inc.

- Conduct chemical analysis of raw materials & in-process testing of cosmetics, fragrances & toiletries.

- Dispensing & sampling of raw materials.

March to August 1996 House of Sara Lee

- Inspection & analysis of finished goods of cosmetics, fragrances & toiletries to ensure that they conform to required specifications.

- Preparation & issuance of inspection results and rejection reports.

- Preparation & distribution of first production-run samples. August 1 august 1995 to February 1996 Marsman Laboratories

- Assist in chemical analysis of in-process testing.

- Conduct visual inspection of raw materials.

- Conduct inspection of incoming packaging materials.

- Conduct on-line inspection of finished goods.

- Prepared inspection results

EDUCATION

1990-1994 Emilio Aguinaldo College Manila

B.S. Pharmacy

Pharmacist Licensure Examination-Passed (1997 July) References:

Available upon request

Contact this candidate