QbD Group's 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 looking for our next QbD’er in Qualification & Validation for the region of Eindhoven.

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

As a Qualification & Validation specialist,you work on multiple projects in the Netherlands within several organizations within the pharmaceutical, ATMP’s or Medical device related industry. You are responsible for effective and efficient validation and qualification of computerized systems, laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices and processes.

Main responsibilities:

• 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 test method 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
• Represents Quality Assurance department in project teams;
• Provide coaching, training and guidance on validations, quality and CSV;
• Ensure change control procedures are followed to maintain the system including its software in a validated state throughout the life cycle;
• Manage and execute periodic reviews;
• 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 a BSc degree in Life Science & Technology, Exact Science, Computer Science or Engineering;
• Experience in QA, computer system validation (CSV) or in automated processes and working knowledge of validation of products/equipment/processes/risk management/data integrity;
• Knowledge of GMP, FDA, EMA and local guidelines
  
• Pro-active, result driven, flexible, detail oriented, and able to function independently as well as in a team.

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 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!