Job Description
Mail:- [Confidential Information]
Pharmaceutical Quality Assurance (QA) role ensures drug products meet safety, efficacy, and regulatory standards by overseeing documentation, processes, audits, and batch release, focusing on building quality into manufacturing (cGMP) through activities like SOP review, deviation investigation, validation, and supplier qualification, preventing errors rather than just detecting them. Key duties include reviewing batch records (BMRs), managing change controls, investigating out-of-specification (OOS) results, conducting audits, and releasing finished products for distribution, all while maintaining compliance with guidelines like GMP, GCP, GDP.
Core ResponsibilitiesDocument Control: Reviewing and approving Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and other quality documents.Batch Record Review: Ensuring manufacturing and packing documents are complete, accurate, and compliant before product release.Process Monitoring: Overseeing online checks, line clearances, and in-process controls during manufacturing.Audits & Inspections: Conducting internal audits and ensuring readiness for external regulatory inspections.Deviation & CAPA Management: Investigating deviations, OOS results, and implementing Corrective and Preventive Actions (CAPA).Validation: Reviewing and approving validation protocols and reports for processes, equipment, and cleaning.Material Control: Approving or rejecting raw materials, packaging materials, and finished goods.Training: Providing GMP training to staff.Key Focus AreascGMP Compliance: Ensuring adherence to Good Manufacturing Practices (GMP).Regulatory Compliance: Staying updated on and implementing relevant pharmaceutical regulations.Risk Mitigation: Designing processes to prevent quality issues before they occur.Essential SkillsStrong understanding of pharmaceutical quality systems (CAPA, Change Control, Audits).Excellent documentation, communication, and analytical skills.Ability to work under pressure and prioritize tasks.A proactive, quality-focused mindset, with attention to detail.
