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

- You have user-level computer skills: word processing, spreadsheet and database.

- You have a strong ability to self-manage and love working in a team. Rigour and proactivity are highly desirable.

- You have excellent communication skills.

- You are an autonomous person with the ability to adapt.

- You are able to adapt to high quality standards, data integrity, GMP.

- A true QbD’er can be recognized by the following qualities:

- Resilient : Your strong and positive attitude helps you overcome any challenge

- Hungry for knowledge : You are always open to learning

- No non-sense mentality : you can be straightforward in a respectful way

- Innovative :



You are constantly looking for new and better solutions

- (Not too) serious : your job is serious, but you don’t take yourself too serious.

What’s in it for you?

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- QbD Group offers you an attractive and competitive salary package , that will be tailored to individual needs, considering legal requirements and local laws and regulations.

- Join us to build a sustainable career , where job security is ensured, and lasting, meaningful connections are formed.

- As we’re a knowledge-based company , you’re guaranteed to embark on a continuous journey of learning and development.

- Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

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- As an ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences.

- Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.

- In short … We stand for? JPEG : J oy in P artnership, going for the E xtra mile to G et things done!

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

Seniority level

Associate

Employment type

Full-time

Job function

Consulting, Project Management, and Science

Industries

Pharmaceutical Manufacturing and Business Consulting and Services

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