For our partner in the Canton of Neuchâtel, Gi Life Sciences is looking for a : Validation Senior Scientist (Temporary contract – 2 years) Your mission : The Validation Senior Scientist will be the expert in validation processes for ensuring that products / processes meet regulatory requirements and quality standards. The incumbent will support all operational aspects of MS&T department including process monitoring / support, change control and deviation closure. This position regularly works cross functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors. Your responsibilities :

• Develop, implement and manage the site process validation strategies to meet cGMP and quality requirements on time and on budget, to ensure that programs are compliant with Regulatory Authorities' expectations and related SOPs.
• Collaborate with cross functional teams to define the interfaces to equipment qualification, system qualification and analytical method validation.
• Establish and maintain the Validation Master Plan for process validation.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.
• Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance performance and drive operational excellence for better quality, safety and efficiency. Your profile :
• Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science
• Minimum 4-6 years of experience in pharmaceutical industry with MSc degree or 7-9 years' experience with BSc (GMP validation experience is considered an asset)
• Strong problem-solving skills, strong verbal and written communication skills
• Must have strong interpersonal & communication skills and be a team player
• Excellent command of English and preferably French language.
• Project and change management experience (Experience with Product Life Cycle Management)
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions and response to audit questions Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton, BauTech and former Kelly Services. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 35 locations across Switzerland and over 250 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts : all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°. Your contact at Gi Group : Marko Durakovic Gi Life Sciences Geneva ... +41 22 737 12 09 Branche : Pharma-Industrie Funktion : Qualitätsprüfung Anstellungsart : Temporäre Arbeit