Roles and Responsibilities Develop, implement, and oversee a comprehensive documentation system in line with WHO GMP guidelines and applicable regulations. Implement and manage robust IPQA procedures to monitor critical manufacturing processes in real-time. Review and verify in-process batch records to ensure accuracy, completeness, and adherence to Standard Operating Procedures (SOPs) Create, review, and approve a wide range of quality documents, including SOPs, batch records, validation protocols, technical reports, and quality agreements. Manage the document control process, including version control, distribution, and archival of controlled documents. Lead the review process for critical documents, ensuring accuracy, completeness, and compliance before approval. Plan, execute, and report internal audits to assess documentation practices, identifying gaps and opportunities for improvement. Manage, mentor, and lead the QA team, providing guidance, training, and support to ensure professional growth and high-performance outcomes. Foster a collaborative and empowered team culture that places a premium on quality, compliance, and continuous improvement. Skill Sets Should have complete knowledge of documentation as per WHO GMP guidelines. Can create and review all the documents. Should have knowledge of IPQA Can manage a team of QA
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