Qualification and Validation Specialist - Barcelona (Rubí)

Qualification and Validation Specialist - Barcelona (Rubí)

09 ago
|
Talent
|
Rubí

09 ago

Talent

Rubí

QbD Groupteam 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 Barcelona 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.

Main Responsabilities:

- 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 3 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 a good understanding of Annex 1 guidelines for validation purpose.

- 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?

- 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 integral success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

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

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📌 Qualification and Validation Specialist - Barcelona (Rubí)
🏢 Talent
📍 Rubí

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