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QA Validation

EXPERIS | Wavre | Durée indéterminée, Temps plein

En ligne depuis 13 jours sur Jobat.be

QA Validation

Description de la fonction

Purpose of the Mission

Provide QA support and oversight to validation activities according to validation procedures

Main Responsibilities

  • Provide a compliance expertise in validation
  • Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
  • Review/Approve the validation documentation regarding the GMP requirements and the Vaccines procedures
  • Ensure that production practice are aligned with validation conclusion
  • Attend all project meetings as QA validation representative
  • Ensure timely escalation to Management of critical issues during validation
  • Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
  • Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
  • Work in autonomy with supervision/coaching
  • To define the validation strategies through the change control process
  • To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review ….)
  • To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
  • To support the production, QA and technical service teams in the implementation of the validation activities.

Experience

  • Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
  • Knowledge of GMP / CFR / Eudralex …
  • Knowledge of different regulations and standards related to validation activites

Soft Skills

  • Good interpersonal relationship skills
  • Good oral and written communication skills in French & English
  • Problem solving and achievement oriented
  • To be a good team player in order to succeed in each validation project and routine activities
  • To be able to use a risk-based approach for problem solving and prioritization of tasks

Education

  • University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)

IT Skills

  • Knowledge of SAP, documentum is an asset.

Language

  • English: good
  • French: Fluent

Profil

Experience

  • Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
  • Knowledge of GMP / CFR / Eudralex …
  • Knowledge of different regulations and standards related to validation activites

Soft Skills

  • Good interpersonal relationship skills
  • Good oral and written communication skills in French & English
  • Problem solving and achievement oriented
  • To be a good team player in order to succeed in each validation project and routine activities
  • To be able to use a risk-based approach for problem solving and prioritization of tasks

Education

  • University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)

IT Skills

  • Knowledge of SAP, documentum is an asset.

Language

  • English: good
  • French: Fluent

Offre

CDI, consultancy

Intéressé(e) ?

Experis Belgium
Catarina Caleja Machado
32 2 639 10 70
Wavre

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Caractéristiques

Exigences

  • Master (Licence, Université ou Enseignement Supérieur de Type Long)

Offre

  • Durée indéterminée
  • Temps plein

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