JR Qualification & Validation Specialist

JR Qualification & Validation Specialist

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QbD Group team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices / IVD. We are always looking for the next QbD’er in Process validation.

What do we expect from you as a Qualification and Validation Specialist?

As a Qualification & Validation specialist, you work on multiple projects in the Netherlands within several organizations within the pharmaceutical or Medical device related industry . You are responsible for effective and efficient validation and qualification of laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices and processes.

• Provide quality and validation oversight to ensure that validation, qualification and other life cycle activities are consistent with company validation policies, procedures and federal regulations;
• Support process validations (IQ / OQ / PQ) and cleaning validation;
• Identify critical areas for improvement and prioritize and execute the initiatives.
• Perform or support nonconformance / CAPA root cause investigations, defining action plans and driving these to completion;
• Proceed according to the company's quality policy in all business activities;
• Provide advice to improve the quality policies and validation procedures
• Provide coaching, training and guidance on validations;
• Implement controls to ensure data integrity and traceability of Quality records;
• Act as a subject matter expert during internal and external audits (e.g. FDA).

Who are we looking for?

What’s in it for you?

Our promise to you :

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!

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