QA Expert

ジョブ番号: 615

外部説明:

QA Expert

This role is to serve as an expert in the key quality management system for Japan subsidiary with regards to GxP requirements as well as Japanese Pharmaceutical Laws. 

Support the Quality Manager with the implementation of the defined Global Healthcare Operations strategy and ensure the implementation and monitoring of the Quality Management System and their continuous improvement. 

Tasks will include the management of key Quality Management Systems such as document system, training, customer complaints, self inspection, Change control, etc.

Another key area of this role is the maintenance of Foreign Manufacturing Accreditation (FMA) for the overseas manufacturing sites.

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Responsibilities:

• Manage Quality Document System throughout the lifecycle of the quality documents (creation, revision, obsolescence) and ensure quality system is aligned with the HCQ standards and compliant with the local regulations; Creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango;  Maintenance of all appropriate documentation via document management system including electronic systems such as Mango.
• Manage Training System to ensure the employees are capable and qualified for the operations according to the quality system; Maintenance of all appropriate documentation and recording  of trainigs via paper or electronic system (HR4You Learning)
• Manage the Customer complaints including (but not limited to) the following activities;  Maintenance of all appropriate documentation, recording and investigation of customer complaints via the complaint database TrackWise; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses)
• Manage Self inspections such as preparation of annual plan, execution of self inspection, reporting of the results and monitoring of CAPA status.
• Responsible for the compilation, tracking and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.
• Implement and monitor corrective actions to guarantee the coherence and efficiency of the individuated operative mechanisms. 
• Manage Foreign Manufacturing Accreditation (FMA) of overseas manufacturing sites including new submission and maintenance of the existing FMAs.
• Assist with audit and inspection management / preparation carried out by the Health Authorities and corporate intrernal audits.
• Assist with Risk Management activities
• Actively participate in the Merck Performance Management Process and Personal Development plan
• Work within company Standard Operating Procedures, industry guidelines and apply Merck Values and Code of Conduct in daily duties and activities.
• Perform other functions and duties that may be assigned by the Head of Quality.
• To recognize a reportable adverse event(AE) and/or safety information which may be related to a Merck products and ensure that the necessary information is forwarded to the Local Patient Safety Responsible Person (LPSR) within 24 hours
• Liaise with quality global functions (HCQ) and site quality to handle quality issues
• Maintain a Quality Management System(QMS) at the Merck BioPharma Japan

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Required Skills:

• At least 3 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / QUALITY operations, Distribution Warehouse management or clinical development activities
• Experience in Good Distribution Practices and Distribution Activity
• Strong knowledge in local applicable laws and regulations
• Willingness and enthusiasm to learn new skills
• Time management skills, ability to prioritise and work in a busy work environment
• Excellent communication skills
• Ability to work within a team environment and with cross functional teams
• A demonstrated proactive, problem-solving mentality with strong analytical skills

ADDITIONAL REQUIREMENTS

• Computer skills (Word, Excel, SharePoint, etc.)
• Knowledge of software packages such as iScala, Trackwise, Documentation Management systems desired, but not essential

ジョブ番号: 615

コミュニティステータス: QA Expert

Location_formattedLocationLong: Tokyo, Tokyo JP