Qualification & Validation Specialist

QbD Group; Barcelona; Presencial; EUR 35.000 - 50.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Attractive and competitive salary package

Continuous learning and development opportunities

Job security and meaningful connections

Descripción de la vacante

A leading pharmaceutical consultancy in Barcelona seeks a Qualification & Validation Specialist. You will ensure compliance with quality and validation standards while providing oversight on validation activities. The ideal candidate has a background in pharmacy, chemistry, or engineering and at least 2 years of experience in qualifications/validations. You can expect a competitive salary, job security, and opportunities for continuous learning. Join us and become part of a vibrant community committed to innovation and collaboration.

Formación

• You have at least 2 years of experience in qualifications/validations.
• Experience in validation documentation management required.
• You should be able to write technical documentation in English.

Responsabilidades

• Provide quality and validation oversight.
• Support process validations (IQ/OQ/PQ).
• Act as a subject matter expert during audits.

Conocimientos

Experience in qualifications/validations

Strong communication skills

User-level computer skills

Teamwork ability

Ability to adapt to high-quality standards

Educación

Academic background in pharmacy, chemistry, biology, or engineering

Herramientas

Validation documentation management tools

Descripción del empleo

Join to apply for the 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: 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 global 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: Joy in Partnership, going for the Extra mile to Get things done!

Interested? 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