Job
Description
Reports To: QA Manager / QA Head Job Summary: The QA Staff - Pharmaceutical Labeling is responsible for ensuring the accuracy, compliance, and quality of all labeling materials used for pharmaceutical products, from raw materials to finished goods. This role plays a critical part in upholding regulatory standards (e.g., cGMP, FDA, local health authorities) and protecting patient safety by meticulously reviewing, approving, and controlling labeling artwork and printed components. Key Responsibilities: Labeling Artwork Review & Approval:Thoroughly review and approve all new and revised labeling artwork (e.g., cartons, labels, inserts, patient information leaflets) for accuracy, completeness, and adherence to approved specifications, regulatory requirements, and marketing claims. Verify content against drug master files, approved dossiers, product specifications, and regulatory submission documents. Ensure proper formatting, legibility, barcoding, serialization data, and all mandatory information are present and correct. Document Control & Management:Manage the lifecycle of labeling documentation, including creation, revision, archival, and retrieval of artwork files, specifications, and related quality records. Maintain an organized and traceable system for all labeling-related quality documentation. Quality Control & In-Process Checks:Perform incoming quality checks on printed packaging materials (labels, cartons, inserts) to ensure they meet specified quality standards and approved artwork. Conduct in-process checks on the production line to verify correct label application, batch coding, expiry dating, and serialization data. Address and document any deviations or discrepancies found during checks. Change Control Management:Initiate, review, and approve change control requests related to labeling modifications, ensuring all impacts are assessed and implemented correctly. Collaborate with R&D, Regulatory Affairs, Production, and Marketing to manage labeling changes efficiently and compliantly. Regulatory Compliance:Stay updated with national and international pharmaceutical labeling regulations (e.g., CDSCO, FDA, EMA guidelines). Ensure all labeling practices and materials comply with current Good Manufacturing Practices (cGMP) and other relevant quality standards. Deviation and CAPA Management:Investigate and document labeling-related deviations, non-conformances, and customer complaints. Propose, implement, and verify corrective and preventive actions (CAPAs) to address root causes and prevent recurrence. Training & Support:Provide support and guidance on labeling best practices and compliance to production and other cross-functional teams. Assist in training relevant
