Qualification & Validation Associate Consultant

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 Qualification/Validation.

What do we expect from you as a Qualification and Validation Specialist?

As a Qualification & Validation specialist, you work on multiple projects in Spain 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.

• 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;
  
  Cualquier información adicional que necesite para este trabajo se encuentra en el texto a continuación. Asegúrese de leerla detenidamente y luego envíe su solicitud.
  
• 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
• Implement controls to ensure data integrity and traceability of Quality records;
  

Who are we looking for?

• You have an academic background related to areas such as pharmacy, chemistry, biology, engineering and related fields.
• You have 1-2 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 : J oy in P artnership, going for the E xtra mile to G et things done!

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

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