Quality Assurance Manager

As a QA Manager in an OSD (Oral Solid Dosage) plant, your role involves overseeing all quality-related activities to ensure products meet required standards and regulations. This includes developing and implementing quality management systems, conducting audits, managing quality control, and leading the QA team. Your key responsibility is to play a crucial role in ensuring compliance with GMP, regulatory standards, and continuous improvement initiatives. Key Responsibilities: - Developing and Implementing Quality Management Systems: - Establishing and maintaining quality policies, procedures, and standards for the OSD plant. - Ensuring Compliance: - Ensuring all products and processes adhere to regulatory requirements (e.g., GMP, FDA, EMA) and company standards. - Conducting Audits: - Performing internal and external audits to assess compliance and identify areas for improvement. - Managing Quality Control: - Overseeing testing protocols for raw materials, in-process samples, and finished products. Collaborating with the Quality Control (QC) team. - Investigating Deviations: - Investigating deviations, non-conformances, and customer complaints, and implementing corrective and preventive actions (CAPA). - Document Management: - Ensuring accurate and timely documentation of all quality-related activities, including batch records, SOPs, and validation protocols. - Team Leadership: - Leading and mentoring the QA team, providing training, and fostering a culture of quality. - Continuous Improvement: - Identifying areas for improvement in quality systems and processes and implementing initiatives to enhance overall effectiveness. - Collaboration: - Working with other departments (e.g., Production, R&D, Regulatory Affairs) to integrate quality practices into all stages of the manufacturing process. - Reporting: - Preparing and presenting quality reports to senior management. - Risk Management: - Identifying and mitigating potential risks that could impact product quality. - Staying Updated: - Keeping abreast of the latest industry trends, best practices, and regulatory changes. Qualifications: - Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field. - Extensive experience (typically 10+ years) in quality control within the pharmaceutical industry, specifically with OSD formulations. - Proven experience (typically 5+ years) in a managerial role with demonstrated leadership skills. - In-depth knowledge of GMP, regulatory requirements (FDA, EMA, etc.), and quality management systems. - Strong analytical, problem-solving, and communication skills. - Proficiency in quality control software and tools. Benefits: - Provident Fund Schedule: - Day shift Work Location: - In person,