Executive QMS Production (Injectable)

Role Overview: You will be responsible for overseeing daily production operations to ensure adherence to quality management system (QMS) standards. Your role will involve supervising manufacturing processes, maintaining production-related documentation, and addressing challenges to minimize downtime and improve efficiency. You will collaborate with cross-functional teams to ensure seamless operations and compliance with industry regulations. Key Responsibilities: - Execute daily production operations and ensure the efficient functioning of the department. - Supervise and monitor manufacturing processes to ensure compliance with quality standards. - Review and maintain production-related QMS elements, including change control, deviation, event investigation, and corrective and preventive actions (CAPA). - Prepare and review Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packing Records (BPRs). - Address and resolve production issues promptly to minimize downtime and ensure continuous production. - Respond to challenges or bottlenecks and implement mitigation strategies within defined timelines. - Ensure that all processes and documentation comply with SOPs and protocols. - Maintain and review all production-related records, including batch records, equipment logs, and production output reports. - Prepare regular reports on production output, efficiency, and quality metrics for management review. - Coordinate with the maintenance department to resolve equipment breakdowns and ensure smooth production activities. - Oversee the document control system to ensure the availability and integrity of quality documents. Qualifications Required: - Bachelor's or Masters degree in pharmacy, life sciences, biotechnology, or a related field. - Minimum of 3 to 5 years of experience in a production/QMS-related role within the pharmaceutical, biotechnology, or manufacturing industry. - Strong understanding of QMS principles, regulatory compliance, and production processes. - Ability to analyze and resolve production-related challenges effectively. - Proficiency in documentation, report preparation, and adherence to SOPs. Company Additional Details: The company website is https://www.biotechhealthcare.com.,