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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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

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 / Masters 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

Working arrangement :

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

Required Skills : Preferred Skills :

Required Experience :

Senior IC

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1