[innovative Medicine] Operational Quality Supervisor (night Shift), Operational Quality Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)

Operational Quality Group Supervisor

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

This Job Description applies to the position of Operational Quality Group Supervisor at JPKK, Fuji Plant. This individual provides quality perspective direction for all production activities at JPKK, Fuji Plant.

Regulatory Compliance Responsibilities:

• GMP/GCTP. Operational Quality Group Supervisor will comply with Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP/GCTP, Narcotics and Psychotropics Control Law all corporate and site policies and procedure.

Major Job Duties and Responsibilities:

Quality Operations Support Activities:

• Operational Support: Assist the Operational Quality Group staff in their daily activities during the night shift, ensuring continuous quality oversight.
• Routine Rounds: Collaborate with night shift staff to conduct routine rounds, ensuring Good Manufacturing Practices (GMP), compliance, and safety standards are consistently met in all GMP areas.
• Incident Reporting: Ensure that any quality and compliance-related events occurring on the shop floor during the night shift are promptly reported to the quality team. Events must be managed swiftly and appropriately by the department responsible, with supervisors providing direct or indirect support during investigations, focusing on identifying root causes.
• Corrective and Preventive Actions: Work in collaboration with managers and supervisors to pinpoint effective corrective and preventive actions that mitigate potential recurrences of issues, thus achieving production goals and minimizing quality and compliance problems. Occasionally lead root cause analysis activities using appropriate methodologies.
• Implementation Oversight: Ensure the timely execution of assigned corrective and preventive actions to address any identified issues.
• Promoting Quality Culture: Support the operations group in fostering a quality culture as an integral part of the systematic approach to all processes.
• Cross-Department Support: Assist various departments by providing necessary solutions to navigate critical situations during night operations.
• Inspection Preparation: Aid in the preparation for external and internal inspections, actively participate in internal audits, and contribute to business processes such as Johnson & Johnson Production System (JJPS) and Kaizen by advocating for the implementation of improvement actions.
• Process Monitoring: Ensure the adequacy of processes and the performance of individual subsystems through regular checks and continuous monitoring.
• Procedure Management: Oversee the issuance and updating of operational procedures (Work Instructions & Standard Operating Procedures), promoting continuous improvement in GMP processes, and supporting projects for new machine and production line installations with timely reviews.
• Training Coordination: Ensure that personnel involved in procedural changes receive adequate training, prepare necessary materials, and conduct the group's annual GMP re-training for operations.
• Technological Innovation: Contribute to maintaining a high level of technological innovation and process improvement by guiding projects and initiatives that follow Lean and JJPS methodologies.
• Performance Indicators: Ensure that performance indicators for the areas of responsibility align with expected results, analyzing and trending defect data appropriately.
• NPI Coordination: Assign team members as Quality Assurance (QA) points of contact for New Product Introduction (NPI) launch activities.

Quality & Compliance:

• Adhere to GMP and compliance regulations while performing all work activities.
• Create, modify, and ensure the updating of necessary procedures and work instructions.
• Complete all assigned technical training and required updates in a timely manner.
• Assist in training and reinforcing compliance measures (such as Data Integrity) within the production area.

Environmental Health and Safety (EHS):

• Work in compliance with established safety procedures and regulations.
• Promptly report any situations that could jeopardize the health and safety of employees or the environment to supervisors.
• Participate in information sessions, training, and health surveillance provided for the job.
• Recognize the significance of Johnson & Johnson's assets and take measures to protect them from theft, loss, or destruction.

Computer & Automation Systems:

• Utilize necessary IT tools effectively to carry out work activities.
• Adhere to Johnson & Johnson's Worldwide Information Asset Protection Policy, recognizing the importance of safeguarding information from unauthorized access, disclosure, and other risks.

Job Requirement:

Education and Experiences:

• Degree in Pharmacy, Science or Engineering is preferable.

Knowledge, Qualification and Skills:

• GMP/GCTP and Data Integrity
• Knowledgeable of quality system
• Pharmaceutical regulations, standards, and guidelines
• Communication skill to articulate Japan needs to stakeholders

Core Competencies:

• Collaboration and teamwork.
• Credo value of integrity.
• Customer focus.
• EHS Comply with EHS rules and procedures at all times.
• Report all incidents, accidents, and near miss events.

This is a night shift position, and the working hours will be 18:45 to 3:45 (Break: 23:00-24:00) with total 8 hours / day. The company may require employees to work outside of regular working hours or on holidays due to business needs.