Qualified/Responsible Person

Functiebeschrijving

Your role as a QP/RP will be to contribute to the implementation and optimization of projects of the infarAMA customers. You will be responsible for a variation of aspects within their projects such as:

• Accomplish QP/RP duties according to the applicable local and EU regulations (RD 14 Dec 2006 – GMP/GDP guidelines): manage and assure continuous improvement of the pharmaceutical quality management system (QMS) and handle quality complaints, rejects, reworks, returns, recalls, change control, deviations and CAPAs
• Batch certification (QP) and release for sale (RP) as primary and back-up QP/RP
• Perform GMP/GDP compliance gap analysis and interact with other departments
• Participate in GMP/GDP/QMS self-inspections and external audits
• Ensure inspection readiness and act as primary contact during Competent Authority inspections
• QA liaison with contract manufacturing organizations or third party logistic providers

Wie ben jij?

• 5 years of working experience in (non-)sterile manufacturing, packaging and labeling and supply chain is an asset
• Industrial Pharmacist, FAMHP certified (RD 14/12/2006 art. 48/EU Dir. 2001/83/EC)
• Knowledge of GMP/GDP/risk management
• Learning attitude and continuous improvement mindset
• Problem solving capabilities
• Result driven, accurate (eagle eye for details)
• Excellent organizational and planning skills
• Team player
• Customer oriented (good communicator and assertiveness)
• Fluent in English and Dutch and/or French

Wat bieden wij jou?

• A varied job with challenging multi-disciplinary tasks in a dynamic and growing environment
• Competitive benefits and compensation packages
• Workplace in Aarschot or in Strombeek-Bever

Taal

Competenties