Strong understanding of usp and ep sterility testing
Comprehensive gmp compliance knowledge including 21cfr210
Hands-on experience in complex contamination investigations
The role is accountable for the compliant, effective, and modern contamination control strategy across Sterile Vertical Operations in Viatris
Job Summary
The role is accountable for the compliant, effective, and modern contamination control strategy across Sterile Vertical Operations in Viatris.
Viatris offers competitive salaries, benefits, excellent career progression opportunities, and an inclusive environment where employees can make a difference.
This position requires acting as a senior advisor on sterile operations strategy while ensuring alignment with evolving Health Authority expectations.
Matching Summary
The role is accountable for the compliant, effective, and modern contamination control strategy across Sterile Vertical Operations in Viatris.
Salary
Competitive salary; Bonus scheme available; Health insurance and pension included
Skills & Requirements
Must-have
Strong understanding of USP and EP sterility testing
Comprehensive GMP compliance knowledge including 21CFR210
Hands-on experience in complex contamination investigations
Technical knowledge of clean room engineering and particle control
Experience with environmental monitoring programs
Nice-to-have
Ability to articulate technical aspects of risk assessments
Collaborative culture fostering courage and resilience
Experience sharing best practices across global sites
Proactive assessment of controls prior to exceeded limits
Key Requirements
Knowledge of ISO 9001:2015, 13485 and Part 11 compliance
Understanding of EU Guidelines Annex 1 and FDA Guidance on Aseptic Processing
Experience with facility designs, flows, zone concepts, and tech transfers