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regulatory pharmacist

3 months ago

Manila, National Capital Region, Philippines EUROHEALTHCARE EXPONENTS, INC. Full time
DUTIES AND RESPONSIBILITIES1. Coordinates with the Food and Drugs Administration (FDA), Department of Health (DOH), and Philippine Drug Enforcement Agency (PDEA); be aware of the rules and regulations applicable to the company as mandated by law.2. Handles registration of all company product's Certificate of Product Registration (CPR) and License to Operate (LTO) including amendments and ensures the updates when it comes to validity and acts as the official custodian of all documents pertaining to Food and Drugs Administration (FDA) requirements.3. Observe the proper implementation and conducting of the company's SOP on:a. Good Distribution Practiceb. Reporting Adverse Drug Reactionsc. Receiving of Finished Productd. Finished Products Returnse. Drug Product Complaintf. Product Recallg. Product Disposalh. Auditing Toll Manufactureri. Evaluation of Packaging Materials Supplier4. Submit all documents needed in different government agencies needed for product/s registration.5. Participates in all necessary training, orientation, and education of all associates who handle or access health information updates.6. Maintain updated batch distribution records. Ensures that all antibiotic products are batch certified and issued by the Food and Drugs Administration (FDA).7. Entertain all inspections conducted by the Food and Drugs Administration (FDA), Department of Health (DOH), and Philippine Drug Enforcement Agency (PDEA). Prepare and submit all documents needed for the compliance of the company if there are deficiencies in the inspection reports.8. To conduct Toll Manufacturing inspection and Vendor Rating annually.9. Monthly monitoring of products available in the warehouse.QUALIFICATIONS:
• Candidate must possess at least Professional License (Passed Board/Bar/Professional License Exam) in Pharmacy/Pharmacology or equivalent.
• Open for Fresh Grad
• Willing to start ASAP
• Willing to work onsite in Quezon CityRequired Skill(s):1. Knowledgeable in MS. Office,2. Adobe Photoshop and Corel Draw3. Application, Knowledgeable in FDA Liason,
• Scope of Work (REGULATORY PHARMACIST)
Summary of role requirements:Looking for candidates available to work:Monday: Morning, AfternoonTuesday: Morning, AfternoonWednesday: Morning, AfternoonThursday: Morning, AfternoonFriday: Morning, AfternoonSaturday: Morning1 year of relevant work experience required for this roleWorking rights required for this roleExpected start date for role: 24 August 2024