Validation & Qualification QA Manager - Biopharma production
Ver: 155
Dia de atualização: 16-11-2025
Localização: Charleroi Hainaut
Categoria: Gestão executiva
Tipo de empregos: Vaste Jobs
Conteúdo do emprego
- Job Description
- Summary
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Added 10/03/2022
- Validation and Qualification QA role within the Healthcare Industry
- Based in Charleroi area - Focus on therapeutic uses
About Our Client
Our client is a growing dynamic biotech company. Their mission is fully committed to helping their clients fulfill their objective of providing sustainable and affordable solutions for subsequent therapic uses.
In order to sustain their growth, they are currently looking for: Validation and Qualification QA manager - Biotech Industry
Job Description
As the successful QA validation manager - you will have the following responsibilities:
- Implement and maintain the production area, premise and equipment
- Validate and Qualify validation new production or QC labs.
- Be the subject matter expert during audit and inspection for all questions related to qualification, validation and data integrity.
- Ensure the facility Validation Master Plan is in place and in use.
- Ensure required Standard Operating Procedures and systems are implemented to support qualification and validation programs.
- Provide quality oversight and support for cleaning, equipment, facility and instrument qualification and validation activities.
- Provide QA support, including review and approval, for deviations, and investigations related to facilities, equipment, equipment failures ensuring events are contained, risks mitigated, impacts to equipment, product and processes adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented.
- Develop and implement ways of working and best practice related to new builds, expansion projects and facility acquisitions
- Ensures the review and approval of documentation related to computerized system, including user specifications, impact assessments, commissioning and validation protocols.
The Successful Applicant
As the successful QA validation manager, you will have the following requirements:
- At least a Master degree in Life Sciences field or equivalent by experience.
- Good knowledge of quality tools: cGMP, Validations ans Qualifications, Regulatory guidelines, Handling or regulatory inspections, well acquainted with Change control / deviation and market compliance management system.
- Experience of minimum 7-10 years in Quality Assurance, or Validation function with a strong familiarity of general GMP documentation and Equipment/Instrumentation (preferably in a biopharmaceutical company).
- Experience with aseptic processing is a plus.
- Knowledge of medical devices is a plus.
- Experience in people management.
- Experience in molecular biology and/or quality control in production environment is a real plus.
What’s on Offer
As the successful QA validation manager, you will have:
An attractive salary package:- Base Salary
- Bonus system
- Position Benefits
- Meal Vouchers
- Full-time position (40h/week).
- An indeterminate contract.
- Company car with fuel card
- Insurances
- Flexibility & Autonomy
The chance to join a market leader and a growing dynamic biotech company in its activities and working in a human-sized working environment with a convivial atmosphere.
Job summary
Data limite: 31-12-2025
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