Job Description

• Quality Assurance Strategy: Develop and implement a comprehensive quality assurance strategy and quality management system to ensure compliance with regulatory requirements, industry standards, and company policies.
• Compliance Management: Ensure that all manufacturing processes, documentation, and testing procedures comply with relevant regulatory standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
• Standard Operating Procedures (SOPs): Develop and maintain SOPs for quality control, quality assurance, and quality management activities. Ensure that these procedures are followed consistently throughout the plant.
• Audits and Inspections: Coordinate and conduct internal and external audits to assess compliance with regulatory requirements and identify areas for improvement. Prepare for and manage regulatory inspections by health authorities or customers.
• Quality Control: Oversee the quality control activities, including raw material testing, in-process checks, and final product testing. Ensure that appropriate analytical methods and equipment are in place and validated.
• Deviation and CAPA Management: Manage the deviation and Corrective and Preventive Action (CAPA) system, including investigating deviations, identifying root causes, and implementing corrective actions to prevent recurrence.
• Change Control: Review and approve change control requests related to manufacturing processes, equipment, facilities, and systems to ensure compliance and minimize quality risks.
• Training and Personnel Development: Provide training and support to personnel on quality systems, regulatory requirements, and quality-related procedures. Foster a culture of quality and continuous improvement within the organization.
• Documentation and Record Keeping: Ensure accurate and timely documentation of all quality-related activities, including batch records, test reports, and validation protocols. Maintain a systematic record-keeping system for easy retrieval and compliance.
• Supplier Management: Collaborate with the procurement and supply chain teams to establish and maintain a supplier qualification program, ensuring that all raw material suppliers meet quality standards and specifications.
• Risk Management: Identify and assess quality risks within the manufacturing processes, implement risk mitigation strategies, and drive continuous improvement initiatives.
• Quality Metrics and Reporting: Define and track key quality performance indicators (KPIs) to measure the effectiveness of quality systems and report on quality trends to senior management.
• Continuous Improvement: Drive a culture of continuous improvement by initiating and leading quality improvement projects, conducting root cause analyses, and implementing best practices.
• Regulatory Compliance: Stay up to date with regulatory changes and industry trends in quality assurance and ensure the plant's readiness for upcoming regulatory requirements.
• Collaboration and Communication: Foster effective cross-functional collaboration with departments such as production, engineering, regulatory affairs, and quality control. Communicate quality-related issues, initiatives, and improvements to stakeholders at all levels.
• Training and counseling of team members as and when required.