QA Validation Consultant – Pharma

CDI

Avenue Jules Bordet 168 1140 Bruxelles

22/09/2023

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Référence

2023-28760

Catégorie

Operations — Engineering/production

Secteur Industriel

Life sciences

Niveau d'expérience

3 à 5 ans

Localisation

Brabant wallon, Wallonie, Belgique

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Description

QA Validation Consultant 
 

For one of our clients, a multinational pharmaceutical and biotechnology company, we are actively looking for a QA Validation Consultant. 


Purpose of the Mission 


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


Key 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 company’s 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 reviewing deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities (Approval must be performed by internal employee) 
  • Pro-actively identify potential quality and compliance  
  • 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 

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 activities 
 
Soft skills: 


Good interpersonal relationship skills 
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 
 
Knowledge: 


SAP, documentum is an asset. 
 
Education: 


University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) 
 
Language Proficiency Requirements 


French - Fluent oral and written communication skills 
English - Good oral and written communication skills 

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Notre Politique d’embauche participe à améliorer la représentation de la diversité au sein des effectifs du Groupe AKKA. Nos recrutements sont donc ouverts à tous les candidats dont le profil correspond aux caractéristiques et exigences du poste, en dehors de toute autre considération que les qualités et compétences professionnelles.