Full-Time · Pasig City · On-Site · ₱40,000 – ₱50,000 / month

You will build the quality system that lets ObraRx pass PH FDA inspection and the system that lets us scale to thousands of prescriptions per month without compromising compliance.

The role

As Regulatory & QA Pharmacist, you own the compliance architecture of ObraRx. You will build our Quality Management System from scratch, draft and lock down the SOP suite that PH FDA inspectors will read, prepare our LTO and minor variation filings, and stand alongside the Pharmacist-in-Charge during pre-licensing inspection. After launch, you own deviation handling, CAPA, environmental monitoring oversight, internal audits, and recall readiness.

This is the highest-leverage hire in the company. The person who builds the QMS becomes Head of Quality as ObraRx scales across the Philippines and Southeast Asia. You will not be filing paperwork — you will be designing the operating system that other compounding pharmacies will eventually be measured against.

What you will do

• Draft, review, and maintain the full SOP suite for sterile and non-sterile compounding
• Prepare and submit the Drugstore LTO, Drug Distributor LTO, and minor variation application for sterile compounding to PH FDA
• Build and maintain IQ/OQ/PQ documentation for cleanroom, BSC, LAF, passboxes, refrigerators, and supporting utilities
• Establish the environmental monitoring program — viable and non-viable particle counts, surface sampling, personnel monitoring, water testing
• Own internal audit, deviation, CAPA, and change control workflows. Lead mock inspections before PH FDA pre-licensing
• Maintain Master Formula Records and batch record templates, in collaboration with the PIC and our US 503B consultants
• Qualify and re-qualify API suppliers, primary packaging vendors, and contract testing labs
• Train pharmacists, technicians, and operations staff on the QMS
• Serve as the primary point of contact with PH FDA, PRC, and other regulatory bodies

What we're looking for

• PRC-licensed pharmacist (RPh) in good standing, with a valid Professional Tax Receipt
• Three or more years of experience, with at least one year in regulatory affairs, QA, or hospital pharmacy with IV admixture or oncology compounding exposure
• Demonstrated experience with PH FDA inspections — either having been on the receiving side or having walked an inspector through a facility