Sr. Specialist
JulpharJob Description
At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees. Job Summary The Sr. Specialist/Team Leader in the OSD plant is responsible for overseeing and managing production/Packaging activities, ensuring compliance with GMP, regulatory guidelines, and safety protocols. The role involves coordinating with cross-functional teams to achieve production targets, maintaining product quality, and optimizing operational efficiency. Key Responsibilities - Production/Packaging Management - Supervise and manage the OSD production/Packaging process, including granulation, compression, coating, and packaging. - Ensure adherence to production/packaging schedules and optimize output while maintaining product quality. - Coordinate with the supply chain, planning, and warehouse teams to ensure smooth material availability. - Troubleshoot production/packaging-related issues and implement corrective and preventive actions (CAPA). - Compliance & Quality Assurance - Ensure all operations comply with cGMP, WHO, SFDA, USFDA, MHRA, and other regulatory standards. - Work closely with the Quality Assurance (QA) team to ensure in-process quality checks. - Handle deviations, change controls, and investigations related to production/packaging activities. - Maintain proper documentation in accordance with regulatory and company standards. - Team Management & Training - Supervise and mentor production/packaging staff, including operators, technicians, and junior executives. - Conduct training programs on SOPs, GMP guidelines, and safety procedures. - Monitor employee performance and provide feedback for continuous improvement. - Equipment & Process Optimization - Ensure the proper functioning, calibration, and maintenance of production/packaging equipment. - Identify opportunities for process improvements and cost reduction while maintaining quality. - Collaborate with the engineering and maintenance teams for timely resolution of equipment issues. - Safety & Compliance - Ensure adherence to workplace safety guidelines and implement safety measures. - Conduct risk assessments and take necessary preventive actions to minimize hazards. - Ensure proper handling and disposal of waste as per environmental and regulatory norms. - Regulatory & Audit Readiness - Prepare the plant for regulatory inspections and customer audits. - Ensure timely completion of all documentation, including batch manufacturing records (BMR), standard operating procedures (SOPs), and validation protocols. - Address audit findings and implement corrective measures. Qualifications & Experience - Education: B. Pharm / M. Pharm / M.Sc. in Pharmaceuticals, Chemistry, or related field. - Experience: 6-10 years of experience in OSD pharmaceutical manufacturing, with at least 2-3 years in a supervisory or managerial role. - Knowledge & Skills: - Strong understanding of GMP, regulatory compliance, and safety guidelines. - Experience in operating and troubleshooting OSD equipment like granulators, tablet presses, coating machines, and blenders. - Leadership and team management skills. - Excellent problem-solving and decision-making abilities. - Strong communication and documentation skills. Work Environment & Additional Information - The role requires working in a controlled manufacturing environment. - May involve working in shifts, depending on production needs. - Requires collaboration with QA, R&D, engineering, and regulatory teams. We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar