Spécialiste en entretien et conformité

Manager, Talent Acquisition & Employee Experience at Jubilant Radiopharma ENGLISH version below Specialist, Maintenance and Compliance Join our dynamic team at Jubilant Radiopharma as Specialist, Maintenance and Compliance We are seeking a driven individual who thrives in a fast-paced environment and is passionate about ensuring the highest standards of quality and compliance in our operations. Why Jubilant Radiopharma? At Jubilant Radiopharma, we are dedicated to making a meaningful impact in the lives of patients by delivering high-quality radiopharmaceuticals. As a leader in the industry, we offer exciting opportunities for professional growth and development, along with a collaborative work environment where your contributions are valued and recognized. Role Overview: As a Specialist in Maintenance and Compliance, you will be responsible for overseeing preventive, corrective, and predictive maintenance programs and ensuring general compliance of maintenance operations with internal requirements, industry best practices, and governmental and regulatory standards. The specialist will also need to stay updated on best practices, identify gaps, recommend, and implement changes to enhance the compliance level of site operations and facilities from a maintenance perspective. Participate in internal and regulatory audit processes to assess compliance and communicate current GMP regulations and the department's and company's policies, guidelines, and procedures. Key resource person for the maintenance department who interacts directly with the investigator group and technicians related to the department's operations. Key Responsibilities: Creation and updating of PM and Calibration plans in the maintenance and calibration CMMS. Responsible for the content (tasks, specifications, range, etc.) of Work Orders (WO) and Preventive Maintenance Directives (PMD). Participation in the planning of PM and Calibrations. Planning of external firms according to the established schedule. Management of parts inventories. Key resource person for investigations concerning maintenance/calibration. Responsible for monitoring the general compliance of maintenance and calibration operations with internal requirements and GMP. Participate in internal and external audit processes. Propose and participate in improvement projects (equipment, services, etc.). Support and follow the investigation process of quality incidents, change control, and CAPA involving maintenance services, to contribute to the establishment of corrective and preventive measures to be applied to maintenance and calibration documents (SOPs, PM and Calibration program documents). Drafting/Review/Approval of WOs/PMDs and closing of WOs in the CMMS. Evaluate site compliance from the perspective of technical programs, identify deficiencies, and act as SME to resolve these deficiencies. Conduct regular checks of the various maintenance service programs to ensure efficiency. Report maintenance performance indicators (KPIs), PM vs. CM, downtime per month vs. planned production time. Perform other tasks as assigned by management. Qualifications: Bachelor's degree in Electrical, Software, or Mechanical Engineering Minimum of 3 years of experience in a pharmaceutical manufacturing environment under cGMP regulations Experience in preventive and predictive maintenance Experience with quality tools such as lean manufacturing, six sigma Experience in radiopharmaceuticals is an asset Good knowledge of regulatory requirements Advanced computer and software skills, including computerized maintenance systems (SAP) French (spoken and written) Member of the OIQ Join Us: If you are looking for a challenging yet rewarding opportunity to make a difference in the healthcare industry, we invite you to apply for the Specialist, Maintenance and Compliance position at Jubilant Radiopharma. Join us in our mission to deliver innovative solutions that enhance patient care and improve lives. Apply now and be part of our success story #J-18808-Ljbffr