Title:
Compliance Lead Investigator
Main Purpose:
To provide Issue and CAPA support to the Logistics Branches. Compliance Lead Investigator will be in charge of opening, completing the impact assessment, investigating, entering the action plan, doing the effectiveness check of the issues where the investigating site or site issue occurred is PHL-LOG. They will be responsible to prepare and manage CIR (Client Issues Report), follow up issues and CAPAs and monitor the metrics.
Main Duties and Responsibilities
- Act as a lead investigator. Open issues and compete the impact assessment. Perform root cause analysis, close deviations, and effectiveness checks.
- Provide guidance on investigations to co-investigators and operational staff, as well as participate in global quality sessions on investigations.
- Issue escalation and mitigation. Identify trends within the investigations team and report findings to management and quality logistics staff.
- Create and expedite Client Incident Report (CIRs)- Investigation summary reports for the clients. Actively participate in calls with customers.
- Assist with CAPA completion as a CAPA owner and identify and suggest robust Corrective and Preventative Actions. Analyze and highlight issue and CAPA trends. Support assignment of proper corrective actions.
- Define and execute training to improve understanding of and compliance with procedures and quality requirements.
- Collaborate with Marken Vendor and Logistics Service Provides to complete investigation and CAPAs.
- Track and communicate process improvements in the region including Standard Operating Procedures.
- Lead and facilitate regional continuous improvement events with the operational excellence team.
- Perform calculation, data collection in support of Marken operations, global initiatives, and management reviews.
- Identify inconsistencies and/or deficiencies in the QMS and report them to the Branch Management and Quality Logistics staff.
- Work closely with local quality coordinators, Quality Managers and Directors.
- Support other Quality Coordinators’ activities as needed.
- Perform weekly metrics on CAPA system (number of issues and CAPAs completed per week, number of issues completed overdue, issues effective versus ineffective).
- To do weekly follow up of the issues and CAPAs.
Requirements:
- Previous experience in Quality Management Systems with an eye for details for pharmaceutical industry.
- Good interpersonal skills, conflict mediation, sense of urgency to complete assignments on time.
- Organized and a mind for paying attention to details, structured and solution driven thinking
- Expertise skills in defining and writing procedures and work instructions and skilled trainer
- Excellent communication and writing skills
- Experience in driving the daily workload and performance based on data and performance KPIs (shipment/milestone reports, KPI matrix etc.)
- Bachelor’s degree or the equivalent combination of relevant education and/or professional experience
General
- To adhere to all company Policies at all times.
- To undertake any other reasonable duties at the request of the Line Manager/ Dot Line Manager.
- Minimal travel to Marken Branches, meetings, vendor’s audits and training.
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
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