Overview
QbD Group 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 will work on multiple projects across the Netherlands within various organizations in the pharmaceutical or medical device industry. You will be responsible for the effective and efficient validation and qualification of laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices, and processes.
Responsibilities
* Provide quality and validation oversight to ensure validation, qualification, and other lifecycle activities comply with company policies, procedures, and regulations.
* Support process validations (IQ / OQ / PQ) and cleaning validation.
* Identify critical areas for improvement, prioritize, and execute initiatives.
* Perform or support nonconformance / CAPA root cause investigations, define action plans, and drive completion.
* Follow the company\'s quality policy in all activities.
* Advise on improving 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 we are looking for
* Academic background in pharmacy, chemistry, biology, engineering, or related fields.
* At least 4 years of experience in qualifications / validations within validation departments in the pharmaceutical, medical devices, or biotech sectors.
* Experience in qualification / validation documentation management: VP, URS, IQ, OQ, PQ.
* Experience with complete validation processes: protocols and reports.
* Nice to have: experience with SCADA qualifications.
* Proficiency in English, capable of writing technical documentation; spoken English is an advantage.
* User-level computer skills: Word, spreadsheets, databases.
* Strong self-management skills, teamwork orientation, rigor, and proactivity.
* Excellent communication skills.
* Autonomous, adaptable, and able to work under high-quality standards, data integrity, and GMP requirements.
* Qualities of a true QbD’er: resilient, eager to learn, straightforward yet respectful, innovative, and able to maintain a balanced attitude.
What’s in it for you
* Attractive, competitive salary package tailored to individual needs, compliant with legal and local regulations.
* Opportunity to build a sustainable career with job security and meaningful connections.
* Continuous learning and development in a knowledge-based environment.
* Be part of a global success story and a recognized, award-winning company that values contributions and celebrates achievements.
Our promise to you
* We aim to provide the best environment for growth within the life sciences.
* We foster a joyful community where you can be yourself and grow together as unique individuals.
* Our motto : JPEG — Joy in Partnership, going the Extra mile to Get things done!
Interested? Send us your CV and motivation letter. Who knows, you might soon join our QbD family!
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