Professional Experiences

Drugmaker’s Laboratories, Inc.

Quality Control Analyst

1. Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance to established standards.

2. Conducts and validates various biological and chemical quality control assays.
3. Compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards.
4. Responsible for establishing specifications for conducting assays and writing standard operating procedures.

Regulatory Affairs Officer

1. Check documents, samples and payment prior submission and submit to the designated government agency.
2. Ensure manufactured products are appropriately licensed, produced and marketed.
3. Check with designated government personnel status application and check and/or receive releases of documents (Certification of Product Registration (CPR), permits and licenses).
4. Prepare documents required for applications and prepare accomplishments reports.
5. Outlining requirements for labeling, storage and packaging and writing comprehensible, user-friendly, clear product information leaflets and labels.
6. Ensuring compliance with regulation set by the Food and Drug Administration.
7. Liaising and negotiating with regulatory authorities.
8. Ensuring the quality standards are met and submissions meet strict deadlines.
9. Maintain accurate inventory of supplies and materials and in good condition.
10. Maintain accurate records, documents, clean and orderly filed
11. Perform other jobs that may be assigned by the immediate superior from time to time.

Validation Analyst

1. Prepares the protocols and templates for all the processes/procedures required for validation.
2. Responsible for implementation and/or execution of the plans/procedures indicated in the approved protocol and template.
3. Communicate to other department regarding the requirements of a specific validation activity during the execution and final reporting.
4. Prepares the protocols and templates needed for the qualification of facilities, equipments, systems and utilities.
5. Communicate to the Engineering Department especially to the Engineering Head regarding the plans, execution s, documentations and reporting of qualifications.
6. Coordinate to other required departments regarding the qualifications activities requirements.
7. Monitor the production/manufacturing process of the given pharmaceutical product.
8. Prepares the production schedule/timetable in regards in validation monitoring.
9. Ensure the correctness of Master Batch Record in terms of manufacturing procedure, analyses, machines and equipment apply, etc.