Validation Specialist

Our Story At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via : Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference, and here’s how the Validation Specialist (Project Based / until end of 2027) role will make an impact: Coordinate process validation activities in compliance with cGMP requirements, global quality standards and regulatory expectations. Prepare, execute, review, and approve process validation protocols and reports including bulk hold-time studies. Act an active role technology transfer activities for new product introductions and manufacturing process changes. Review and assess process transfer documentation to ensure successful implementation into commercial manufacturing Prepare Continued Process Verification (CPV) activities and annual process monitoring programs. Ensure Data Integrity requirements are incorporated into validation studies through risk-based assessments. Participate in change control assessments and provide validation expertise for manufacturing process changes. Conduct risk assessments using Quality Risk Management principles (FMEA, etc.). Collaborate with Manufacturing, Quality Control, Regulatory Affairs and Supply Chain teams to ensure validated processes remain in a state of control. Support internal audits, regulatory inspections, and customer audits by providing validation documentation and technical expertise. Contribute to continuous improvement initiatives aimed at enhancing process robustness, compliance, and operational excellence. About Your Skills & Experience For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Bachelor's Degree in Pharmacy, Chemical Engineering, Chemistry, Biotechnology, Industrial Engineering, or a related scientific discipline. Minimum 2–4 years of experience in pharmaceutical validation (oral solid dosages), quality assurance, manufacturing or related GMP functions. Strong understanding of cGMP requirements and pharmaceutical quality systems. Experience in Process Validation Lifecycle activities and Continued Process Verification. Knowledge of Annex 15, FDA Process Validation Guidance and ICH requirements. Knowledge of Data Integrity principles and risk-based validation approaches. Strong technical writing skills with the ability to prepare clear and compliant protocols and reports. Excellent communication skills in both English and Turkish. Proficiency in Microsoft Office applications. At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles. Why Viatris? At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives. Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility