Senior Quality Engineer; Qualification & Validation – Equipment & Facilities

Senior Quality Engineer (Qualification & Validation – Equipment & Facilities)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Location:

Courcelles, Hainaut, Belgium.

• The function holder.
• Ensures and supports Operations of European Distribution Center (DC Courcelles) in Good Distribution Practices in the warehouse.
• Assists the Site Quality Head in implementing and maintaining Quality System DC Courcelles.
• Works in line with Credo Values, Supply Chain and J&J Deliver Requirements.
• Works in line with the J&J Safety, Health and Environmental principles.
• Participates to the process improvement as process owner.

• Audits & inspections
  • Leads, supports and follows-up of internal and external inspections.
  • Supports and actively participates to quality internal/external audits.
  • Performs proactive GAP analysis against applicable requirements and/or regulations and sets-up corrective actions to support business continuity.
  • Includes audits preparation, audits completion and audits follow-up.
• Change control
  • Initiates, assesses and/or approves Change Controls related to DC distribution activities and repackaging activities.
• Documentation
  • Writes, (periodic) reviews and/or approves Work Instructions (WI) and Procedures (SOP).
  • Collaborates with other departments for documentation content and ensures Good Documentation Practices are followed.
  • Archives quality documents and/or repackage/relabel records following the record retention period and archiving system.
• Improvement
  • Provides data/information for the Quality Improvement Plan (QIP) and the Quality Management Review (QMR) meetings.
  • Supports and performs trend analysis and proposes corrective actions where needed.
  • Reviews and improves processes of the QMS, ensures that KPIs are in place.
  • Participates to the process improvement as process owner.
• Non-conformities & Delivery Service Issues
  • Initiates, assesses, investigates and/or approves Quality Issues, Corrective and Preventive actions and Delivery service issues related to distribution activities to avoid reoccurrences.
  • Assesses if record is applicable for escalation and initiates appropriate process.
• Project
  • Participates, follows up and/or leads development of projects implementation in collaboration with Operations, Region and/or Franchises.
  • Provides QA Team with project progress on a regular basis.
• QA on the floor
  • Supports operations to work in compliance with GMP (where applicable) and GDP requirements.
  • Performs Gemba Walks on a regular basis.
  • Joins weekly operational kick-off.
  • Works actively and proposes operational improvements.
• Qualification & Validation – Equipment & facilities
  • Is involved in the periodic requalification of equipment or qualification of new equipment related to distribution.
  • Coordinates the validation, calibration and qualification of equipment.
  • Follows-up activities related to facilities with potential quality impact.
• Risk management
  • Identifies, prioritizes and mitigates quality risks related to QA and operational processes.
• Training & Qualification
  • Delivers qualification to warehouse personnel to ensure operational personnel has an appropriate understanding of the process/activity.
  • Reviews training curricula and creates training materials (where applicable).

• Refer to essential knowledge section.
• Current Good Documentation practices.
• ISO 13485.

• Know-how of systems.
• JDE 8.12.
• ETQ.
• Truvault.
• Summit.
• Microsoft Office applications.

• Higher education / Master’s degree.
• QA related experience within an operational pharmaceutical environment.
• Knowledge of quality system processes such as Training, Document Management, Change Control, CAPA, Investigation, Audit.
• Knowledge of…