Qualification & Validation Specialist

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?

As a Qualification & Validation specialist,you work on multiple projects in the Netherlands 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 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?
Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family