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Qualification & Validation Specialist

role at

QbD Group

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?

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?

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 documentation in English. Spoken English will also be an advantage as you will be joining a multinational company.

You have user-level computer skills

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