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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?

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- 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?

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- You have an academic background related to areas such as pharmacy, chemistry, biology, engineering and related fields.
- You have at least 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 technical documen

📌 Qualification & Validation Specialist (Barcelona)
🏢 QbD Group
📍 Barcelona