JR Qualification & Validation Specialist

JR Qualification & Validation Specialist Join to apply for the JR Qualification & Validation Specialist role at QbD Group

Direct message the job poster from 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?

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.

• 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.

Provide advice to improve the quality policies and validation procedures

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!

Seniority level Associate

Employment type Full-time

Job function Consulting, Project Management, and Science

Industries Pharmaceutical Manufacturing and Business Consulting and Services

We’re not including referral or site-wide boilerplate content here to keep the description focused.

#J-18808-Ljbffr