Senior Qualification & Validation Specialist

Senior Qualification & Validation Specialist (80-100%) Ophtapharm AG is an FDA/EU-GMP certified producer in the pharmaceutical sector (ophthalmics). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, -ointments, and -gels are aseptically produced, filled, and packaged for international markets. The Qualification & Validation team ensures the qualified and validated state of equipment, systems, premises, and processes, thereby contributing significantly to the GMP-compliant manufacture of our ophthalmic medicinal products. In doing so, it works closely with Production, Engineering, and Quality Assurance. To strengthen our team, we are looking for an experienced and committed person as Senior Qualification & Validation Specialist (80–100%) starting immediately or by arrangement. Senior Qualification & Validation Specialist (80-100%) Your Role Planning, implementation, and coordination of qualification and validation activities for equipment, systems, premises, and processes. Ensuring the qualified or validated state of GMP-relevant systems and facilities. Responsibility for qualifications, cleaning validations, CSV activities, and the associated GMP documentation. Participation in deviations, CAPAs, Change Controls, and Product Quality Reviews (PQRs). Technical support for cross-departmental projects as well as active co-design of processes, standards, and compliance requirements. Your Profile Degree (Uni/FH) in engineering, natural sciences, or a comparable field of study. Several years of professional experience in a GMP-regulated pharma or life science environment. Sound knowledge of qualification and validation, ideally in aseptic manufacturing. Confident handling of GMP requirements and quality-relevant documentation. Very good German and English skills as well as a structured and communicative way of working. What is included Key role with direct influence on quality, compliance, and the further development of the site. Opportunity to actively help shape processes, structures, and standards in a changing company. Broad area of responsibility with close cooperation across Quality, Production, and Engineering. Professional and personal development opportunities in a demanding GMP environment. Attractive pension fund, free parking spaces, and good accessibility via public transport. For recruitment agencies: Thank you for your interest. We do not work with external recruitment partners to fill this position. Work location Ophtapharm AG Riethofstrasse 1 8442 Hettlingen CH Do you have questions? HR Hettlingen, Human Resources, will be happy to answer them. Tel: . Apply now jpid2374233jm jit0832jm jiy26jm