[OFER-TRABEC] NAC: Consumer Complaint Investigations professional

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Bolsa de empleo: http://www.biocat.cat/es/bolsa-de-empleo
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(c)OFER-TRABEC es un servicio ofrecido por el Centro de Comunicaciones RedIRIS
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Institución:Pharma-Bio Serv S.L.
Contacto correo-e:DDunkle@pharmabioserv.com
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Pharma-Bio Serv has an opportunity for an experienced Consumer Complaint Investigations professional.
This is initially a 3 (three) month contract with potential for extension to 6 (six) months located in central Germany.
Interested candidates must be EU Citizens with fluent German and English languages.

Suitable candidates shall have:
• Degree in a relevant Science.
• Fluent German and English.
• Two to four years over the counter and prescriptive drugs investigations or complaint management.
• Basic Level of applicable Drug, Cosmetic, Food and/or Medical Device Regulations and Standards, including cGMP's and Quality System Regulations (e.g. 21 CFR Part 820.198 Complaint Files).
• Demonstrated understanding of plant manufacturing technologies, systems and products.
• Awareness of complete end to end production process and the systems that support them.
• Experience with Trackwise (intermediate level).
• Experience using various Problem Solving tools for root cause analysis.
• Experience with Salesforce, C3S, Quality Windows, and/or Discoverer would be desirable.

Job Description:
Site QA Complaint Investigations Leader
Consumer Complaint Investigations are a critical component to ensure company compliance with regulatory requirements around the globe. Investigations serve as a key process check and product improvement process to ensure company products meet and delight our consumers.

Responsibilities:
• Owns consumer complaint management systems for the plant/site to include all reports and documentation (i.e. Complaint analysis, SOPs).
• Manage site complaint investigation process which includes complete and timely investigation of complaints to root cause with CAPAs as needed.
• CAPA creation and completion using Trackwise.
• Investigations - concise and timely closure and approval.
• Oversee product returns for analysis (chain of custody, storage and disposal/destruction).
• Leads site Complaint System Data trending, analysis and reporting.
• Lead and develop appropriate action plans to improve quality, decrease consumer complaints, and reduce risk.
• Interfaces with Plant QA & Operations.
• Show leadership to review site performance and escalation of issues when needed.
• Represents site on Sector Complaints Central Team at regular Sector data review sessions and management reviews.
• Understanding of Quality Systems, Metrics, and Tools.
• Develop and maintain relevant site SOPs.
• Work with Site QA Manager and Plant Leadership Team to ensure compliance with site SOP's and associated plant systems.



• Primary Site contact with BU QA Complaints Central Team to review specific action plans and risk mitigation activities related to individual complaints, complaint analysis, and/or as identified as part of signal detection reviews.
• Collaborates with site team to thoroughly investigate issues, get to root cause and enrolls others as needed to complete corrective and preventive actions (CAPAs).
• Escalates complaint activity and/or emerging trends to Plant QA & Operations leadership to evoke immediate attention/action as needed.
• Supports plant based CC systems (e.g. IWS/Q Pillar) and training that will provide for a robust and sustainable investigation capability across the plant that will facilitate robust and holistic CC investigations, management and continuous improvement (e.g. reduction of executional complaints, stronger process control strategies, communication of success stories and recognition).
• Collaboration – Not only at site level but as a key member of a global Sector Organization. Interaction across management levels.
• Problem Solving – Ability to use latest company tools to understand root cause off complaints and be part of the process to address these.
• Leadership – Opportunity to provide guidance and direction to an entire site with respect to Consumer Comments.



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Información complementaria de la oferta:
If you fulfill the requiremensts and are interested in a new challenge, please send your C.V. to: DDunkle@pharmabioserv.com

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