Quality Engineer Complaint Investigation - Belgium, Italy, Puerto Rico
- Support Complaint investigation for Janssen Product Quality Complaints
· Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failure modes have been analyzed and documented prior to complaint closure.
- Review and monitor complaint investigation practices across different departments to ensure the standard process is followed.
- Identify gaps, redundancies, and inaccuracies to improve the complaint investigation process. Drive technical and process improvement and influence change.
- Use statistical/data-driven processes and documentation to support investigations.
- Partner with stakeholders (Manufacturing Sites, PDMS, Contact Centers (LOC), Global Medical Safety, Marketing, PQM, Sales Administration, Brand Protection, ESIQ, etc) to gain knowledge of products and processes
- Actively manage customer relationships (with JJQS, LOCs, Manufacturing Sites, PDMS, GMS, ESIQ, Product Quality Management, IT, Business Partners, etc).
- Create and maintain WI’s and SOP’s related to root cause investigation for complaint management processes.
- Develop and deliver training for colleagues, investigational sites and other partners on complaint investigation process, and product specific information.
- Provide guidance and expertise to internal and external business partners for the interpretation, implementation, and execution of Quality System Regulation requirements related to product complaint investigation.
- Manage projects (complex investigations and new business projects) and collaborate across departments and sites
- Support Regulatory and Field Actions Committees and Health Authority Inspections
- Cooperate with R&D and New Product Introduction teams to ensure new product readiness
- Present complaint investigation outcomes to senior management and interact with different stakeholders to recommend improvements and improve overall risk of the product
· 3+ years of experience in Pharmaceutical industry is required (or other regulated industry such as Medical Device or Consumer sector).
- 1-3 years of experience in Complaint Management, post Market Surveillance and/or Vigilance is required.
- Experience in Risk Management or Compliance experience is a strong asset
- Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR Part 210 and 211 and ICH Q10 and CFR 820.198. is a strong asset.
- Green Belt Certification in Lean or Six Sigma is a plus
- Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA, and DMAIC is a plus
- You have a demonstrated ability to manage complex projects, priorities and multiple tasks.
- You combine strong communication and negotiation skills with a collaboration and team focus.
· You have a continuous improvement mindset and are able to initiate and implement optimization projects
· You can work independently in a global environment/virtual team
· Ability to develop a complaint handling system to meet process and compliance requirements.
· Support technical teams toward business goals (including IT partners).
· Ability to allocate and balance competing priorities
· Ability to engage and align with other diverse and dispersed organizations and functions and lead an organization through continuous improvement and change
· Fluent in English
· Ability to travel internationally as needed
· Ability to work outside of normal working hours when needed.
Europe/Middle East/Africa-Italy, North America-United States-Puerto Rico-Gurabo
Janssen Pharmaceutica N.V. (7555)