Qualification & Validation Specialist

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 : 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