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

Overall purpose of job:

• 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.

Essential duties and responsibilities:

Audits & inspections

• Leads, supports and follows-up of internal and external inspections.
• Supports and actively participates to quality internal/external audits.
• Performs pro-active GAP analysis against applicable requirements and/or regulations and sets-up corrective actions to support business continuity.
• This include 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 ensure Good Documentation Practices are followed.
• Archives quality documents and/or repack/relabelrecords 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, assess, investigates, and/or approves Quality Issues, Corrective and Preventive actions and Delivery service issues related to distribution activities to avoid reoccurrences.
• Assess 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)

Special requirements:

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

Other features of the job:

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

Essential knowledge and skills:

• 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 all QMS elements or local regulations
• Analytical thinking, risk assessment, communication and managerial skills

Core competencies required for this role:

• French and English
• Good knowledge of Microsoft Office applications (Word, Excel,…)
• Good knowledge of Good Documentation Practices
• Team player
• Problem solver – structured & analytical way of working
• Result oriented
• Can work independently, well organized, able to set priorities and escalates issues if needed.
• Excellent verbal and written communication skills

Hybrid Work