Quality Assurance Associate
il y a 2 semaines
- Ensures and supports Operations of European Distribution Center (DC La Louvière) in Good Distribution and Manufacturing Practices in the warehouse and in the repackaging department.
- Assists the Site Quality Head in implementing and maintaining Quality System EDC La Louvière.
- Works in line with Credo Values, Janssen Supply Chain and J&J CLS Requirements.
- Works in line with the Safety, Health and Environmental principles.
- Participates to the process improvement as process owner.
Role Objective
Ensure continuous Quality Oversight of the Belgium Center of Excellence Pharm Repack.
Work in close collaboration with Operations, Supply chain and Commercial organizations. Active participation in meetings to continuously improve the quality, compliance, and the overall customer satisfaction.
Key Responsibilities
Audits & inspections
- Coordinate, Support and followup of internal and external inspections.
- Qualification & Validation _
- Coordinate the validation, calibration, and qualification of equipment.
- Followup activities related to facilities with potential quality impact on products
- System _
- Local QA point of contact for system related (eWM, EU2, aTTP) issues
- Temperature control _
- Local QA point of contact for Temperature monitoring of the warehouse
- Supplier Management _
- Coordinate the supplier management activities (including suppliers' approval
Packaging activities
- Act as Quality Assurance representative ( back up) within the Repack team.
- Review and approve GMP documentation, including Batch records, related to repack activities of finished products to ensure that:
- These are free of error,
- These are compliant with GMP and internal SOP requirements
- Material and printed components are compliant prior to use.
- Write, review and/or approve Work Instructions (WI) and Procedures (SOP)
- Collaborate with other departments for documentation content and ensure Good Documentation Practices are followed.
- Participate to the process improvement as process owner.
- conformities & Complaints
- Initiate, investigate Quality Issues, Correctives and Preventives actions and complaints related to distribution activities and repackaging activities.
- Participate in the development of projects implementation in collaboration with Operations.
- Support operations to work in compliance with GMP and GDP rules.
- Identify, prioritize and mitigate quality risks related to QA and operational processes
- Deliver GMP/GDP training to warehouse and repackaging personnel to ensure operational personnel has an appropriate understanding of the GMP/GDP.
Qualifications:
Career Development Opportunity
- Gain experience in a GxP ( GDP + GMP) with the Quality eyes
- Networking opportunity
- Exposure to audit and managers across different functions
- Projects
- Working in an onsite team
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