QA Officer Validation

Sharp is an international player in pharmaceutical packaging with locations in the USA, UK, Netherlands, and Belgium. In Belgium (Hamont-Achel), we assemble, label, and package pre-filled syringes, injection pens, and vials. With more than 65 years of experience, our Belgian site designs and implements high-quality packaging solutions. We offer contract packaging services such as packaging design, serialization, QP market release, and artwork services. Our focus is on flexible, customized, and excellent customer service.

The Validation Officer is responsible for bringing and maintaining the validation of systems, processes, installations, and equipment within the organization at the desired level. In doing so, legal frameworks and particularly pharmaceutical guidelines and regulations must be observed, and a strategy must be determined, partly in consultation with the quality managers of customers.

• Performing internal audits and guiding external audits (internal, customers, notified bodies) within the framework of validation.
• (Having) setting up, implementing, and ensuring validation studies, in consultation with employees from Operations, Supply Chain, Technical Service, and QA.
• (Having) documenting all validation activities and validation results.
• Contributing to the improvement and optimization of personnel, processes, systems, and implemented procedures.
• Drafting procedures regarding validation activities.
• Assessing the required validation following (proposed) changes in systems, processes, installations, or equipment.
• Ensuring that the validation of systems, processes, installations, and equipment is initiated and implemented in a timely manner.
• Ensuring that the performed validation activities are of a good level and comply with the current international laws and regulations in the field of validation and GMP.
• Ensuring that implemented changes do not affect the validation status of systems, processes, installations, and equipment.
• Minimum bachelor's degree in Industrial Sciences.
• A few years of experience within a pharmaceutical production environment is a plus.
• Familiar and acquainted with GMP guidelines, pharmaceutical guidelines, knowledge of microbiology, hygiene, etc.
• Experience with quality systems, procedures, training, etc.
• Can work with MS-office.
• Good knowledge of English (written and spoken).
• Experience in writing reports.
• Driven personality.
• Ownership.
• Can organize tasks independently and set the right priorities, as well as work in a team.
• Purposeful.
• Analytical.