QA associate, Distribution Center

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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, La Louviere, Hainaut, Belgium

Job Description:

General Mission

The function holder for DC Beerse (DC BEE):

• Ensures and supports Operations of European Distribution Center (DC Beerse) 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 Beerse
• Works in line with Credo Values, Janssen Supply Chain and J&J Deliver Requirements.
• Works in line with the Safety, Health and Environmental principles.
• Participates to the process improvement as process owner.

Specific Responsibilities

Operational activities and Quality System Management – DC Beerse

• Audits & inspections
• Lead, support and follow-up of internal and external inspections.
• Support and actively participate to quality internal/external audits and check rounds. This includes audits preparation, audits completion and audits follow-up.

• Batch/products disposition activities
• Provide release of the batch decision for GMP Low Risk repack activities
• Assess and align the batch status (product disposition) of repacked products according to the decision of the QP Manufacturing or delegated QP for visual control activity of GMP High Risk repack activities, as per TV-FRM-29708 (RP activities delegation list).
• Align the batch status in order to establish shipments under quarantine (before the final QP release of the products), as per TV-FRM-29708.
• Act as back-up for EDN QA team, for any other batch disposition activities and version management.
• Change control
• Initiate, assess and/or approve Change Controls related to distribution activities and repackaging activities.
• Documentation
• 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.
• Improvement
• Provide data/information for the Quality Improvement Plan (QIP) and Quality Management Review (QMR) meetings.
• Review and improve processes of the QMS, ensure that KPIs are in place.
• Participate to the process improvement as process owner.
• Non- conformities & Complaints
• Initiate, investigate and/or approve Quality Issues, Correctives and Preventives. Actions and complaints related to distribution activities and repackaging activities.
• Project
• Participate in the development of projects implementation in collaboration with Operations.
• Support improvement project within EDC and prepare the organization to take up new responsibilities as result of other projects.
• QA on the floor
• Support operations to work in compliance with GMP and GDP rules.
• Qualification & Validation – Equipment & facilities
• Coordinate the validation, calibration and qualification of equipment.
• Follow-up activities related to facilities with potential quality impact on products (pest control, temperature monitoring).
• Q-shipment
• Prepare/approve the required documents to establish shipments under quarantine (i.e.: before the final QP release of the products).
• Repack activities
• Act as Quality Assurance representative 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 requirements,
  • Material and printed components are compliant prior to use.
• Approve the recipe linked to serialization
• Provide the result of the visual Control to the manufacturing sites