Senior QA Specialist, Process Validation

Senior QA Specialist, Process Validation

Lonza

Visp, Switzerland

In this role, you will be QA responsible for the compliance of process validation with main focus on Small Molecules including validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

What you will do:

• Ensure the manufacturing processes: 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

What we are looking for:

• Academic degree in Chemistry or any related field
• Significant experience in the area of small molecules manufacturing, preferably in a validation function as well as strong background in cGMP
• Broad knowledge of manufacturing processes in GMP environment
• Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
• Fluency in English language is required; good German language skills are preferred
• Managing internal and external customer relations professionally and effectively