Job Type: Part-time

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 / ContractIndustry: Pharmaceuticals / Nutraceuticals / Natural Health Products (US & Canada markets)About the RoleWe'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 ResponsibilitiesReview Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for completeness, accuracy, and compliance with cGMPCross-check formulation sheets against approved master formulas and product specificationsReview Certificates of Analysis (COAs) from suppliers/labs for raw materials and finished productsVerify documentation aligns with US FDA 21 CFR Part 111 (dietary supplement cGMP) or 21 CFR Part 210/211 (pharmaceutical cGMP), as applicableVerify documentation aligns with Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) requirements, including Site Licence (SL) and Product Licence (NPN) documentation standardsFlag deviations, missing entries, out-of-spec (OOS) results,



or documentation gaps for follow-upSupport preparation of documentation for FDA inspections or Health Canada auditsMaintain accurate logs of reviewed records and escalate discrepancies to the QA leadCoordinate with production, formulation, and regulatory affairs teams (async) on clarificationsRequirementsBachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Biotechnology, or related field1–3 years of experience in pharma/nutraceutical QA, QC, or regulatory affairsWorking knowledge of cGMP documentation practices under US FDA (21 CFR 111 or 210/211) and/or Health Canada NNHPD frameworksFamiliarity with NPN (Natural Product Number) licensing documentation and/or FDA dietary supplement labeling/claims requirementsStrong attention to detail and ability to spot inconsistencies in technical/regulatory documentsComfortable working independently and reviewing documents digitally (PDFs, ERP/QMS software)Strong written English for documentation and communicating with a North American teamNice to HaveExperience with QMS software (MasterControl, TrackWise, Veeva Vault, or similar)Prior work supporting FDA 483 responses or Health Canada compliance auditsExposure to herbal/natural health formulations, dietary supplements, or OTC monograph productsUnderstanding of stability testing, shelf-life documentation, and structure/function claims reviewWhat We OfferFully remote, fixed 4-hour evening shift aligned with North American mornings (no weekend work)Flexible part-time role — valuable fit for experienced professionals seeking supplemental workExposure to US/Canada regulatory and quality processes in a growing natural health products company

📌 QA Associate – Batch Records & Formulation Review (Part-Time, Remote – Evening Shift) (Madhya Pradesh)
🏢 Pureoyl Healthcare
📍 Madhya Pradesh