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 Qualification/Validation.
What do we expect from you as a Qualification and Validation Specialist?
As a Qualification & Validation specialist, you work on multiple projects in Spain 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
- Implement controls to ensure data integrity and traceability of Quality records;

Who are we looking for?
- You have an academic background related to areas such as pharmacy, chemistry, biology, engineering and related fields.
- You have 1-2 years of experience in qualifications/validations within validation departments in the pharmaceutical sector, medical devices, biotechnology...
- You have experience in qualification/validation documentation management: VP, URS, IQ, OQ, PQ.
- You have experience in complete processes of validations: protocols and validation reports.
- You have an advanced level of English: you should be able to write

📌 Qualification & Validation Associate Consultant (España)
🏢 QbD Group
📍 España