Quality Systems Specialist
1 maand geleden
Transforming the lives of patients with rare, debilitating, and life-threatening diseases requires a strong foundation in quality systems. As a Quality Systems Specialist at Pharming Group N.V., you will be instrumental in ensuring compliance with current EU and USA GMP legislation for computerized systems.
The role involves evaluating, analyzing, and preparing documents for use, validation, and qualification. You will advise employees and managers on QA-related matters regarding computerized systems, ensuring that all such systems are qualified and validated in accordance with regulatory requirements.
About the Position
- Main Responsibilities: Writes, implements, reviews, and maintains SOPs, policies, and QA-related documentation aligned with GxP guidelines; acts as trainer, coach, and expert regarding computer system validation; sets requirements for configuration, validation, implementation, and maintenance of automated quality systems.
- Tasks and Deliverables: Configures, creates, and evaluates validation, implementation, and maintenance documents for the system; resolves problems and conducts investigations associated with configuration, validation, implementation deviations, Change Controls, Risk Assessments, protocols, and reports; communicates and negotiates with contractors and suppliers regarding deviations, configuration, validation, implementation, and complex projects.
- Skills and Qualifications: Bachelor's or University degree in biopharmaceutical sciences, (bio)chemistry, engineering, ICT, or equivalent; six years of experience in a (bio)pharmaceutical environment with at least four years in Quality Assurance, including at least three years of experience in qualification and validation of computerized systems.
What We Offer
- A permanent position with an excellent remuneration scheme, including a highly competitive salary of around €65,000 per year, holiday allowance, minimum vacation days, excellent pension plan, and commuting allowance.
- An opportunity to join our Learning & Development program, which offers a tailor-made development plan and learning opportunities throughout the company.
- A healthy life-work balance with a lot of flexibility.
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