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Qualification & validation engineer

Geel
Pauwels Consulting
Publiée le Publiée il y a 17 h
Description de l'offre

Join a fast-paced environment where your expertise will significantly contribute to vital validation projects in the healthcare manufacturing sector. Our client is looking for a dedicated professional who is excited about ensuring compliance and excellence in regulatory practices.As an ideal candidate, you are a skilled Validation Specialist focused on delivering high-quality results and driving improvements in regulatory compliance. If you have a keen eye for detail and a passion for operational integrity, this role could be the right fit for you.You develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for small scale equipment, including related software.You perform qualification of systems while interpreting standards according to specific cases in alignment with cGMP, cGLP, and internal procedures.You ensure that the qualified status of systems remains compliant with cGMP at all times.You support projects by adhering to all required cGMP regulatory standards.You keep up-to-date on emerging validation regulations and testing practices to not only meet but exceed cGMP requirements.You are responsible for validation documentation throughout its approval and implementation phases.You provide input in reviewing and assessing changes to determine their impact on qualified status and validation documentation.What are we looking for?You have at least 2-4 years of experience working in a healthcare manufacturing environment with small scale equipment qualification.You possess strong knowledge of cGMP requirements in a regulated environment.You understand relevant quality and compliance regulations.You are capable of troubleshooting validation issues effectively.You bring good knowledge of quality management systems.You demonstrate excellent attention to detail and analytical skills.You are proficient in English.

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