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QA Computerized System Validation Specialist (M/F)

September 8th 2020

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The QA Computerized System Validation Specialist is focus in the maintenance  and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidances and Catalent policies/procedures.
  • 1. Pharmaceutical Quality System

Update, in compliance with the current regulation the QA quality system documents.

Identify and determine quality improvement and recommend appropriate solutions.

  • Subject Matter expert covering QA questions, related to the Computerized System and Validation & Qualification by customers or internal teams.
  • People

Have the appropriate training before realizing an activity.

Participate to meeting related to QA department

Implement an empowerment culture.

Maintains opened and effective communication with all other department.

  • Self Inspection

Update the Self Inspection quality system documents.

Realize self inspection.

Realize QA on the floor.

Update and take adapted action to ensure the CAPA follow up

  • Production ,Area, Premise and Equipment : realize periodical check in production
  • Qualification, validation & calibration

Update qualification, validation and calibration quality system documents.

Update the Validation, Qualification and Calibration Master Plan (site and projects).

Review and approve the protocols emitted to give the assurance they are compliance with the current regulation.

Review and approve the reports emitted to give the assurance they are compliant to the protocols.
  • Continuous Improvement

Implement pertinent tools of operational excellence “Lean culture”

Implements and follows-up Key Performance Indicators

Candidate profile

At least Graduate level in Sciences or have min. 5 years of experience regarding Computerized System Valiation in GMP environment.
  • Experience in quality assurance, documentation and protocols review (without contradicting the Education level section)
  • Fluency in French: good speaking, reading and writing skills,
  • Good reading comprehension and writing skills in English.
  • Computer skills:  Microsoft office, ETQ, ComplianceWire, Documentum, TrackWise are a plus.
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
  • Delivers Results
  • Leads with Integrity and Respect
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Offer

  • Full-time position (40h/week).
  • A determinate contract (6 months).
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere.

Contact Details

To apply for this job, please send your application on the following link : https://bit.ly/3bA9Wus