(Janssen) Operation Quality Staff 品質オペレーション スタッフ {Contract}

職務 概要 Position Summary
:
• This Job Description applies to the position of Operational Quality Group Staff at JPKK, Fuji Plant.
• This individual provides quality perspective direction for all production activities at JPKK, Fuji Plant
法規制の順守に関する責任
Regulatory Compliance Responsibilities:
• Operational Quality Group Staff will comply with the 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.
主な職務及び主な責任
Major Job Duties and Responsibilities:
To execute the Major Job Duties at the Operations area under the supervision of the supervisor, based on training assigned, the individual must:
• Guarantee any quality and compliance related events on the shop floor are reported to quality. The events must be managed promptly and appropriately by the responsible department and the staff must support directly or indirectly on the related investigations in accordance with company procedures with focus identification of the root cause.
• In collaboration with the Managers of the areas involved identifying effective corrective and preventive actions to avoid the potential recurrence of the problem, in order to achieve production objectives and reduce Quality and Compliance problems. At times, must also lead root cause analysis activities using appropriate tools.
• Ensure the timely implementation of corrective and preventive actions assigned.
• Support the Operations group to ensure that quality culture is integral part to the systematic approach to processes.
• Correct application of the procedural and legal requirements for the management of narcotics and their precursors.
• Ensure effective assistance to the Production Service by providing solutions necessary to overcome critical situations.
• Guarantee the management of non-conformities in compliance with GMPs and business procedures.
• To manage, in support of the process owner of the "Batch record" subsystem: the documentation of non-conformities, deviations and defects of products and / or processes; the situations of deviation and their assessment and investigation, including proposed actions appropriate corrective; the investigation on rejected; the rework; data trending.
• Guarantee the "QA on the Shop Floor" process in order to ensure the presence in Operation Execution departments, strengthening the state of compliance, ensuring the execution of the controls of the most critical operations performed on the shop floor identifying opportunities for improvement.
• Ensure the adequacy and completeness of reporting and trend analysis of quality indicators of the establishment.
• Ensure the adequacy of processes and performance of their own subsystem, through periodic checks and continuous monitoring, for identify, in a timely manner, systematic gaps or potential situations of non-compliance.
• Ensure the correct application of the procedures, providing training for the personnel involved when necessary
• Ensure the adequacy, operational alignment and possible revision of all the procedures and work instructions relating to the membership system.
• Ensure the Plant-to-plant meeting are held on a monthly basis for all the responsible sites based on the sites "QA on the Shop Floor" activities.
品質およびコンプライアンス
Quality and Compliance
• Sensitize employees to compliance and GMP regulations by guaranteeing complete implementation of the same.
• To guarantee the updating of one's own and all technical and general knowledge people in their area of responsibility through timely and continuous technical training.
• Ensure the correct creation, application and updating of SOPs in in line with Compliance and GMP regulations.
EHS
• As a staff behave safely, making sure conditions are right the working environment, machinery and systems are healthy and safe, promptly informing their superior of any anomalies and in case of imminent serious danger by interrupting individual and / or collective activities.
• Check that the procedures and internal rules on the Environment, Safety and Occupational Hygiene are known, applied and respected by the staff.
• Ensure that staff carry out health surveillance and training required by the job.
• See Johnson & Johnson's assets as a critical business asset which must be protected from theft, loss, destruction, vandalism, non-access authorized and malicious acts in general.
コンピュータおよびオートメーションシステム
Computer & Automation Systems
• Ensure the correct use of the tools through adequate control information technology necessary for carrying out work activities.
• Comply with the worldwide criteria for protecting the information assets of Johnson & Johnson. Johnson & Johnson acknowledges that information is a crucial business asset that must be protected from non-disclosure authorized, theft, loss, destruction, unauthorized modification, non-access authorized and denial of availability.
教育 / 経験
Education and Experiences:
Degree in Pharmacy, Science or Engineering is preferable.
知識,資格,及び技能 Knowledge, Qualification and Skills:
• Knowledgeable of quality system.
行動特性 Core Competencies
:
• Collaboration and teamwork.
• Credo value of integrity.
• Customer focus.
• Comply with EHS rules and procedures at all times.
• Report all incidents, accidents, and near miss events.
その他
Others:
QA on the Shop Floor Guideline fulfillment.