Quality Assurance Senior Associate & QP

For one of our clients located in Brabant Wallon, I’m actively looking for a Quality Assurance Senior Associate & QP.

  • Do you have a Scientific Master Degree in industrial Pharmacy and 5 years of relevant experience?
  • Are you recognized as Qualified Person by FAMHP?
  • Are you fluent in French and English?

Then you might be the candidate we are looking for. Don’t hesitate and apply now!

Responsibilities 
  • You review and update Quality Agreements/Contracts with key Service Providers 
  • You are responsible of the QA to process Change Controls, deviations and CAPA’s related to manufacturing, Quality Control and distribution 
  • You write, review and approve SOPs, validation protocols and reports 
  • You execute risk assessment exercises 
  • You are QA support for Change Controls related to new material/service introduction/change 
  • You perform new material/service QA assessment (quality questionnaire, quality agreement, analysis of certificates etc.) 
  • You support the QC department to create material specifications, maintain existing specifications 
  • You maintain approved supplier and material lists, create audit plans 
  • You create new articles and maintain current articles in electronic resource management system and assure link with QA approved material list 
  • You are subject matter expert on raw materials/ services used for the manufacturing of products 
  • You are responsible for deviations related to material/service provider issues 
  • You regularly meet key suppliers/service providers’ representatives to follow-up on ongoing issues and implement improvements 
  • You are responsible for supplier change notifications 
  • As Deputy QP, you are in charge of the coordination of product release within the operational group 
  • You act as Deputy Qualified Person
Profile 
  • You are recognized as Qualified Person by FAMHP (must). 
  • You hold a Scientific Master degree in Industrial Pharmacy
  • You have minimum 5 years of relevant experience 
  • You have good knowledge of GMP and GDP within the bio-pharmaceuticals environment, preferably in product development or early clinical stages 
  • You have experience with regulatory inspections 
  • You have experience with Advanced Therapy Medicinal Products (ATMPs) (advantage)
  • You are autonomous 
  • You have strong communication skills 
  • You are creative; thinking out of the box 
  • You can take the lead 
  • You demonstrate knowledge of Quality Systems and risk management tools 
  • You have excellent organizational skills and strong attention to details 
  • You work precisely as per procedures, rules and regulations 
  • You have team spirit 
  • You have negotiation skills 
  • You have excellent English and French knowledge (oral and written) 
Contact Information 

Amandine Planche
+32 10 68 53 30
amandine.planche@valesta.com

Application form : Quality Assurance Senior Associate & QP

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