Process Validation Coordinator

For one of our clients in the pharmaceutical industry, we are currentlylooking for Process Validation Coordinator

Start: ASAP
Length: 6 months + extension
Location: South of Brussels

MISSION DESCRIPTION

Apply the Validation methodology for automated equipments qualificationin the frame of local infrastructure projects respecting cGMP of EU, USand all other applicable regulations.

KEY RESPONSIBILITIES

- In the context of investments projects (new or upgrades) in vaccineproduction, ensure proper execution of the validation methodology andapplication of cGMValidation Master Plan, Design Qualification,Installation & Operational Qualification, Performance Qualificationand Validation Reports) and specific regulations applicable to the"computer" domain (such as FDA's 21 CFR Part 11 or Eudralex Annex 11).
- Ensure the application of Global SOPs (such as Change Control,Incidents Management, Access Management, Backup and Restore, ) for theprojects the coordinates.
- Manage, schedule, coordinate and track each qualification or validationactivities to ensure timely completion of the validation plan incoordination with Production, Technical, Quality Control, QualityAssurance and Regulatory departments.
- Monitors that validation deviations are properly generated, managed andcompleted.
- Coach the User, Technical Services, Validation and QA regarding thevalidation methodology applied to automated systems.
- Reports significant issues the identified to the Validation Manager hereports to.

EDUCATION/KNOWLEDGE/PREVIOUS EXPERIENCE REQUIRED

Education
* University level (engineering, automation, IT, ) or equivalent byexperience.

Knowledge
* Bilingual French/English (spoken and written)
* Knowledge of main automation and IT principles and components (PLC,SCADA/DCS, HMI, network, )
* Knowledge of process control part of standard automated systems, suchas:

o Autoclaves
o Bio reactors/fermentors
o CIP/SIP
o Water loops
o Centrifuges

* Knowledge of good practices in electronic records management
* Knowledge of risk analysis methods applicable to computerized systems(such as FMEA)
* Good knowledge of projects and qualification steps, includingcommissioning.
* Planning of activities

Regulations and standard guidelines:

* cGMP
* Specific regulations and guidelines applicable to computerizedsystems (such as 21 CFR Part 11 (FDA), Annex 11 (EMEA)
* GAMP 5 on Risk Based Approach to Compliant Computerized Systems
* ICH Q9 on Quality Risk Management

Experience
* Have already demonstrated success in implementing its discipline inminor or major projects.
* 2 - 4 years experience in process control validation
* Good skills and competencies level in validation activities organization, understanding and implementation of validation practicesin projects, time schedule, team working,
* Coaching and communication skills
* Good knowledge in coordination of activities,
* Good expertise in GMP Practices (V cycle, GAMP)
* Ability to work under heavy pressure due to the requested flexibilityand reactivity of the activities
* Autonomous
* Ability to work in project teams in a multidisciplinary environmentand a matricial organization
* Quality oriented
* Experience as suppliers auditor would be an advantage