QA Regulatory Compliance Officer - 製薬会社

Location: Tokyo
Contract Type: Permanent
Salary: ¥7000000.00 - ¥11000000.00 (年収)
Specialization: Life Science (Medical Devices / Pharmaceutical / Chemical / Healthcare / Agriculture / Livestock),
Sub Specialization: QC / QA,
Contact: Yoshiko Kumakura
Reference: JO-2201-466700

☑Foreign business
☑English language required
☑Japanese language required

[Position]
QA Regulatory Compliance Officer

[Company Description]
外資系製薬会社

[Responsibilities]
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.

  • 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 our Performance Management Process and Personal Development plan
  • Work within company Standard Operating Procedures, industry guidelines and apply our 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 our 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 exhibition

[Requirements]

  • Bachelor's Degree with a minimum of 3 years of experience in the Pharmaceutical industry.
  • Background in Pharmacy, Life sciences, Pharmacology, Medicine or a related scientific discipline or other related field
  • 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
  • Computer skills (Word, Excel, SharePoint, etc.)
  • Knowledge of software packages such as iScala, Trackwise, Documentation Management systems desired, but not essential

[Language Requirement]

  • English Language level: Upper middle level
  • Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
  • Work permission in Japan required

[Salary]
7〜11 million JPY
※Experiences and skills will be considered

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2201-466700
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance