Location: Remote (India-based)
Shift Timing: 7:00 PM – 11:00 PM IST (4 hours/day, Monday–Friday) — overlaps with North American business hours (9:30 AM–1:30 PM ET / 6:30 AM–10:30 AM PT)
Employment Type: Part time / Contract
Industry: Pharmaceuticals / Nutraceuticals / Natural Health Products (US & Canada markets)
About the Role
We're looking for a QA Associate with a pharma or natural health products background and working knowledge of US FDA and Health Canada regulatory frameworks to remotely review batch manufacturing records, formulation documentation, and quality certificates. This role ensures our products meet regulatory standards for the North American market before release, working a fixed evening shift that overlaps with our US/Canada team's morning hours.
Key Responsibilities
Review Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for completeness, accuracy, and compliance with cGMP
Cross-check formulation sheets against approved master formulas and product specifications
Review Certificates of Analysis (COAs)



from suppliers/labs for raw materials and finished products
Verify documentation aligns with US FDA 21 CFR Part 111 (dietary supplement cGMP) or 21 CFR Part 210/211 (pharmaceutical cGMP), as applicable
Verify documentation aligns with Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) requirements, including Site Licence (SL) and Product Licence (NPN) documentation standards
Flag deviations, missing entries, out-of-spec (OOS) results, or documentation gaps for follow-up
Support preparation of documentation for FDA inspections or Health Canada audits
Maintain accurate logs of reviewed records and escalate discrepancies to the QA lead
Coordinate with production, formulation, and regulatory affairs teams (async) on clarifications
Requirements
Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Biotechnology, or related field
1–3 years of experience in pharma/nutraceutical QA, QC,

📌 QA Associate – Batch Records (India)
🏢 Pureoyl Healthcare
📍 India