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Job Description:

Job Summary

The KAOE team offers comprehensive support and collaboration to Key Account clients, with a focus on operational analysis, detailed investigation reports, regular client communication, and continual process improvement.

This team is responsible for managing incidental issues that may arise throughout the client lifecycle, ensuring prompt and effective resolution while promoting ongoing enhancements to increase client satisfaction and retention.

By leveraging the capabilities of each streamline, the KAOE team addresses client concerns, applies long-term solutions, and works to maintain consistent client experience.

The three streamlines have specific functions related to operational investigation standards and compliance for Key Accounts. The Writer conducts operational technical investigations, the Lead is responsible for client liaison and operational compliance, and the Improvement Specialist focuses on process optimization and data analytics.

These roles have distinct responsibilities and skill requirements but operate collaboratively to support consistent operations and enhance client satisfaction.

KAOE Investigation Writer:

• Ensures every operational investigation report is clear, accurate, and fully documented.
• Conduct investigations for Key Account deviations, ensuring accuracy and completeness. Document all findings clearly and promptly in investigation reports.
• Collaborate with subject matter experts across departments to gather necessary information.
• Perform effectiveness checks for Key Account deviations.
• Ensure compliance with client requirements (QTA, COP) and internal standards.
• Maintain accurate data and documentation for investigations.

KAOE Investigation Lead:

• Acts as the single, accountable point of contact for clients on all GxP matters and contributes to strong business relationship.
• Act as the single point of contact for Key Account clients on all GxP matters.
• Attend regular client meetings (weekly, biweekly, monthly, business reviews).
• Review investigations for compliance and completeness.
• Ensure CAPAs (Corrective and Preventive Actions) are completed on time, with evidence documented.
• Maintain and update investigation dashboards for clients.
• Track and communicate process improvements, including updates to SOPs and client documentation.
• Build and maintain strong client relationships.

KAOE Improvement Specialist:

• Drives continuous improvement by analysing trends and recurring issues.
• Monitor internal trends and identify recurring investigations.
• Analyze data and KPIs to support continuous improvement.
• Support identification and implementation of robust CAPA tasks to prevent repeat issues.
• Design and enhance databases and reporting tools for investigation analysis.
• Lead projects and changes with SMEs from all areas (department and/or global).
• Track and communicate process improvements, including updates to SOPs and client documentation.
• Collaborate with management to align operational goals with business objectives.

General

• Escalate and mitigate incidents as necessary, working closely with department managements.
• Actively participate in both internal and external meetings, ensuring timely updates are provided to management and colleagues.
• Work with other departments to solve client issues.
• Work on multiple investigations / projects and timelines simultaneously, following strict deadlines and escalating issues promptly to ensure timely resolution.
• Promptly identify and flag potential risks to ensure deliverables remain on schedule.
• Participate actively in team efforts to improve the work environment, product quality, efficiency, and other business initiatives.
• Ensure completeness, accuracy, consistency, validity, uniqueness, and integrity of all data and documentation in relevant systems.
• Share knowledge and best practices with peers, staff members, and newly appointed team members to maintain efficiency and compliance.
• Stay informed about, and comply with, regulatory changes, client documentation, and Marken procedures to ensure full compliance with all requirements.
• Regularly review and update processes, ensuring lessons learned and evolving best practices (including external benchmarks) are adopted.
• Adhere to all company policies at all times.
• Undertake any other reasonable duties as requested by line managers, in accordance with company policies.

Employee Type:
 

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