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 MedTech, 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. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Courcelles, Hainaut, Belgium

Job Description:

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
• 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:

• Iso 13485

• Refer to essential knowledge section.
• Current Good Documentation practices
• 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:

Other Features Of The Job:

• Know-How Of Systems

• Jde 8.12

• Etq

• Truvault

• Summit

• Microsoft Office Applications

Essential Knowledge And Skills:

• 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

Working Arrangement:

3 days working on site and 2 days working from home per week.

Required Skills:

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment