Shubham Patil

Quality Assurance Officer @Crescent Pharma Ltd

London, GB

As QA Officer for unlicensed (“specials”) medicinal products, I ensure that every patient‑specific batch meets EU‑GMP standards despite the absence of a full marketing authorisation. I drive robust quality systems—from documentation through product release—to guarantee safe, compliant supply of bespoke medicines.Key Responsibilities:Documentation Control & ArchivingIssue, approve and archive batch records, SOPs, technical agreements, QC specifications and related forms under strict GMP requirements for unlicensed products.GxP Training ManagementMaintain and update the GxP training matrix and tracker; ensure all personnel are trained on special‑product procedures and regulatory exemptions.Quality Systems OversightMonitor, log and close change controls and deviations specific to specials manufacture; lead self‑inspections to identify and remediate gaps.GMP/GLP ComplianceGenerate, review and approve all GMP/GLP documentation for each special‑product batch, ensuring traceability from raw material to patient delivery.Supplier & Manufacturer QualificationCompile and review qualification dossiers for sources of starting materials, solvents and excipients used in unlicensed product manufacture.Batch Record ReviewReview Batch Packaging Records (BPRs) for each specials batch, verifying compliance with EU‑GMP and risk‑based release criteria.Cross‑Departmental GMP Monitoring:Conduct routine audits of production, QC and warehouse functions, with a focus on the unique handling, storage and labelling requirements of specials.Artwork & Labelling Management:Oversee creation, review and approval of patient‑specific label artwork—ensuring accuracy of dosage instructions, patient details and regulatory disclaimers.