Randstad Inhouse Services is looking for a QA Manager: Process Validation Specialist for Lonza AG. (80-100%). The position is temporary until 31.10.2021.
Key responsibilities:
Ensure the manufacturing processes for APIs and Intermediates are in a validated state during their whole lifetime according to Lonza procedures, and in compliance with regulatory guidance
Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
Leading the process validation teams including communication with customers
Preparation of the validation protocols and reports for the studies performed at manufacturing scale
Assessment of changes and deviations during manufacturing for their impact on validation
Preparation and maintenance of a documented continued process verification plan
Key requirements
Master Degree in Chemistry (PhD preferred)
Good English skills
Proficiency in writing scientific reports
Experience in GMP manufacture preferred
Excellent communication skills
Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
Managing internal and external customer relations professionally and effectively