Spclst, Quality Systems & Compliance

Job Description

Position Overview

The Specialist Quality Systems & Compliance is an individual contributor who supports key GQP Quality Assurance activities on behalf of the Marketing Authorization Holder (MAH). The role plans and executes assigned quality tasks proposes improvements to procedures and processes and reviews / analyses quality data and documentation to ensure compliance with internal standards global requirements and applicable regulations.

Essential Functions and Responsibilities (Includes but are not limited to)

The Specialist Quality Systems & Compliance is responsible for:

1. Quality Assurance (Marketing Authorization Holder / GQP Activities)

• Ensure assigned Quality Assurance activities are conducted in compliance with company policies/procedures global requirements and all applicable governmental regulations.
• Plan establish and maintain robust local procedures and documentation to support implementation of Quality Assurance activities as defined in GQP regulations.
• Critically assess and analyse Quality Systems and their implementation to confirm that procedures are appropriately followed and effective.

• Participate in company audits and regulatory inspections of GQP operations by supporting audit / inspection preparation activities and responding to auditor inquiries within area of responsibility acting as a subject matter expert.

• Support the generation documentation and tracking of CAPAs as part of the audit/inspection and GQP selfinspection process including analysis of root causes followup on effectiveness checks and annual trend analysis.
• Propose and support implementation of proactive and continuous improvements to GQP processes based on data/trend analysis selfinspection outcomes and audit/inspection results.

2. Product Market Release & Quality Compliance

• Plan and perform market release activities for products including management and monitoring of the release schedule ensuring a robust and compliant release process.
• Ensure Quality Agreements are in place with all manufacturers and support periodic review to confirm they continue to meet the intent and requirements of GQP.

• Ensure Quality Standard Codes for all company products are maintained reviewed and kept current.
• Gather and review company production data for the Statistics of Production by Pharmaceutical Industry Survey for monthly reporting to the Health Authority.

• Support the coordination and execution of product recall activities across a crossfunctional team including collection and analysis of data related to scope impact and effectiveness of recall actions.

3. Training Systems & Computerized Systems Validation

• Coordinate and implement elements of the GQP training program including planning annual training needs proposing training content updates and analysing training completion and effectiveness metrics.
• Support Computer System Validation activities related to GQP systems in alignment with internal and regulatory expectations including review and analysis of validation documentation and proposing improvements where appropriate.

4. CrossFunctional & Global Collaboration

• Collaborate closely with the Office of the Marketing Supervisor General Regulatory Affairs Pharmacovigilance local manufacturing sites and global sites to execute the above responsibilities.
• Plan and participate in crossfunctional meetings and discussions to support efficient issue resolution information sharing and continuous improvement in Quality & Compliance activities.
• Propose and support implementation of harmonised practices and process improvements across local and global stakeholders based on analysis of best practices quality performance and regulatory expectations.

5. New Product Launch & Regulatory GMP Compliance

• Participate as a Quality representative in crossfunctional new product launch projects by providing Quality & Compliance support and helping ensure readiness compliance and robust launch executions.
• Support regulatory GMP compliance inspections (Pre-Approval Inspections) of foreign and domestic manufacturers for New Product Applications Partial Change Applications and Periodic GMP inspections including support for remediation of identified GMP gaps.
• In collaboration with manufacturers and Regulatory functions support team execution of the Conformance Review process to analyse compliance of site practices with approved marketing authorizations and propose appropriate followup actions where gaps are identified.
• Establish and maintain local procedures related to regulatory GMP compliance inspections and conformance review activities ensuring they remain current and effective.

The Specialist Quality Systems & Compliance is also responsible for:

• Supporting initiatives to enhance digital capability within the Quality function including contributing to the identification evaluation and implementation of digital solutions to improve efficiency of Quality Assurance activities and processes.
• Assisting in regulatory surveillance activities in collaboration with the Office of the Marketing Supervisor General or via participation in industry associations by monitoring changes in Japan regulations and relevant guidances supporting impact assessments and helping share knowledge within the organization to maintain ongoing compliance with local requirements.
• Identifying proposing and communicating opportunities for simplification and continuous improvement within area of work and contributing to team efforts to analyze the current state and implement improvements.

Qualification and Skills Requirements(Includes but are not limited to)

Education

• Bachelors degree in pharmacy Pharmaceutical Sciences Life Sciences Chemistry Engineering or a related scientific discipline is required.
• Advanced degree (e.g. Masters) is an advantage but not required.

Experience

• Approximately 35 years of relevant experience in pharmaceutical Quality Assurance Quality Compliance Regulatory Affairs or a related GxP function.
• Experience with GQP GMP and MAH responsibilities is strongly preferred.
• Experience supporting inspections audits or selfinspections including CAPA management and documentation.

Technical / Professional Skills

• Good understanding of pharmaceutical quality systems and relevant regulations (e.g. GQP GMP GxP MAH requirements local regulatory expectations).
• Ability to plan and prioritise multiple quality activities and deliverables within agreed timelines.
• Strong analytical skills including the ability to review and analyse quality data trends and documentation to identify issues and propose solutions.
• Ability to draft review and maintain quality procedures reports and technical documentation with attention to detail and accuracy.
• Familiarity with CAPA management deviation/investigation processes change control and selfinspection programs.
• Basic understanding of Computer System Validation principles and their application to GQPrelevant systems is desirable.

Competencies & Behaviours

• Proactive solutionoriented mindset with the ability to propose practical improvements to processes and procedures.
• Strong collaboration skills and ability to work effectively in crossfunctional and crosscultural teams.
• Good communication skills (written and verbal) with the ability to clearly present analysis recommendations and decisions to stakeholders.
• High level of integrity and commitment to quality compliance and patient safety.
• Detailoriented organised and able to work independently as an individual contributor while seeking guidance when appropriate.
• Continuous improvement mindset with willingness to challenge the status quo and contribute ideas to simplify and enhance processes.

Language

• Fluency in Japanese (written and spoken) required.
• High English proficiency (written and spoken) with a TOEIC Listening & Reading score of at least 700 or an equivalent level of proficiency (e.g. IELTS 6.0 or EIKEN Grade Pre-1) is required.

Required Skills:

Preferred Skills:

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