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!
- 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
- 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)
+32 10 68 53 30