[Innovative Medicine] Complaint Handling Quality Staff, OQ Group (Fuji Plant)

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The Complaint Handling Quality Staff is accountable for complaint handling activities as complaint handling staff/investigator including confirming and assessing field samples executing the investigation documenting investigation activities and conclusions in the complaint record and driving the record through closure in accordance with applicable procedures and regulations. The role ensures that relevant information and evidence are collected investigation activities are appropriately coordinated with required stakeholders risk and potential root cause are assessed based on objective evidence and the final investigation outcome is clearly documented to support timely and compliant complaint closure.

This is a site-based role applicable to complaint handling staff / investigators responsible for site-owned complaint records including complaints received from other company affiliates for products manufactured at the site. The scope includes confirming and assessing field samples and related complaint information executing and documenting site-based investigation activities coordinating required inputs from applicable functions sites affiliates laboratories and external partners and driving the complaint record through timely and compliant closure. The role supports alignment on investigation approach evidence rationale conclusion and follow-up actions across functions and sites as applicable while ensuring that the investigation record remains complete accurate and inspection ready.

Complaint Handling Staff / Investigator

• Execute site-based complaint investigations in accordance with applicable procedures and regulatory requirements including field sample confirmation objective evidence assessment and coordination with required functions affiliates sourcing sites laboratories and business partners.
• Document investigation activities in the complaint record including assessment of batch manufacturing laboratory distribution field sample and other relevant information as applicable.
• Evaluate potential root cause recurrence trend and risk; identify the need for escalation or additional investigation; and ensure follow-up actions including NC or CAPA linkage when applicable are defined assigned and tracked.
• Prepare clear complete and accurate complaint documentation including the investigation narrative evidence summary rationale conclusion and closure information while driving timely complaint closure.
• Support process monitoring trending continuous improvement transparency timely escalation inspection readiness and a strong quality culture at the site.
• Perform other responsibilities as assigned by the supervisor in support of site quality objectives business priorities and compliant complaint handling operations.

• Global complaint team assigned investigation contributors and cross-functional stakeholders (e.g. Manufacturing QC Engineering Supply Chain Packaging MSAT).
• Other sites and affiliates (as applicable) to align investigation strategy evidence and outcome for site-manufactured product complaints.
• Quality leadership for escalation risk communication and alignment on investigation approach or follow-up actions.
• External manufacturers/partners and laboratories (as applicable) to obtain and evaluate investigation input and analytical results.

• Knowledge of complaint handling site-based investigations field sample assessment quality event management cGMP Good Documentation Practices and applicable regulatory expectations in a regulated environment.
• Ability to collect assess and interpret objective evidence including field samples batch records manufacturing and laboratory data distribution information procedures and other relevant records.
• Ability to conduct structured investigations assess potential root cause recurrence trend and product or patient risk and confirm that conclusions are supported by objective evidence.
• Ability to identify the need for additional investigation escalation NC or CAPA linkage and follow-up actions in accordance with global and site procedures.
• Strong written communication analytical and documentation skills to prepare clear investigation narratives evidence summaries rationales conclusions and closure information.
• Ability to work independently and collaboratively coordinate cross-functional inputs manage multiple complaint records meet deadlines and drive timely closure.

• Bachelors degree in Life Science or related discipline (or equivalent experience) is required.
• Minimum of 2-4 years of experience performing documenting or supporting quality investigations (complaints deviations nonconformances or similar quality events).
• Experience working within quality systems and with applicable regulatory and compliance requirements.
• Demonstrated ability to prepare clear concise complete and actionable investigation documentation.
• Proven critical thinking problem-solving and decision-making skills.
• Strong organization prioritization and time management skills.

• Collaboration and teamwork.
• Strong commitment to Credo values.
• Customer focus.
• Comply with EHS rules and procedures at all times.
• Report all incidents accidents and near miss events.

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