Plant Complaints Coordinator

Plant Complaints Coordinator

Our client Baxter is a multi-international healthcare company. They focus primarily on creating products to treat certain diseases. They are currently searching for a Plant Complaints Coordinator to join their team.

 

The chosen applicant will be:

• Investigating complaints related to medical devices and pharmaceutical end products including review of batch file, sample analysis, root cause investigation and identification of corrective/preventive action plan;
• Analyzing trends and performance using statistical tools;
• Ensuring compliance of the customer complaint handling process with GMP, MDD and Baxter procedures;
• Communicate quality issues to the hierarchy in a factual and accurate manner and initiate the field action process if necessary;
• Documenting non-conformances, investigations, and CAPA in accordance with quality systems requirements;
• Acting as a subject matter expert in internal and external audits;
• Ensuring timely documentation and closure of customer complaints, non-conformances and CAPA records related to complaints;
• Liaising with internal clients, various subject matte experts (for example: R&D scientists, DPOs) and CMOs (applicable to medical devices manufactured by CMOs);
•  Generating data and charts for quality forums such as CAPA Review Board, Management Review and Tier Meetings;
• Generating and capturing KPI results in the appropriate system for customer complaints; and,
• Providing training on relevant procedures.

 

The ideal candidate will have:

• Bachelor’s degree or master’s degree in sciences or other related fields;
• First experience in Quality Assurance;
• Strong analytical ability and problem solving skills;
• First experience with Trackwise is a plus;
• Commitment to quality demonstrated through adherence to Good Manufacturing Practices (GMP) rules;
• Proficiency in English and, ideally basic knowledge of French;
• Excellent interpersonal skills, including being a team player, analytical, proactive, respectful of rules and procedures, rigorous and organized; and,
• Critical and inquisitive mindset.

 

 

The information requested during registration is necessary for misco to match both candidate and employer expectations. Upon expiration of the closing date misco will be informing candidates of the Company’s identity prior to forwarding any applications.

 

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