Senior QA Lead, Process Validation - Small Molecules (Visp)

Lonza; Schweiz; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist (f/m/d) in Process Validation for the expansion of our team at our Visp site. You will be QA responsible for compliance of process validation with main focus on small molecules, including validation activities at scale, continued process verification and PQRs.

The role requires a chemistry degree, substantial experience in small molecule manufacturing with strong cGMP, and the ability to interact with internal teams and regulatory

Qualifikationen

• Academic degree in Chemistry.
• Significant experience in small molecules manufacturing, preferably in a validation function.
• Strong background in cGMP and regulatory expectations.
• Experience interacting with internal interfaces and with regulators (Swissmedic, FDA, etc.).
• Fluency in English is required; German language skills are preferred.
• Managing internal and external customer relations professionally and effectively.

Aufgaben

• Ensure the manufacturing processes for APIs and Intermediates are validated throughout their lifetimes according to Lonza procedures and regulatory guidance.
• Prepare comprehensive process-specific Validation Master Plans describing required studies for process validation.
• Lead process validation teams and coordinate with customers.
• Prepare validation protocols and reports for studies conducted at manufacturing scale.
• Assess changes and deviations during manufacturing for their impact on validation.
• Prepare and maintain a documented continued process verification plan.

Ausbildung

Academic degree in Chemistry

Jobbeschreibung

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist (f/m/d) in Process Validation for the expansion of our team at our Visp site. You will be QA responsible for compliance of process validation with main focus on small molecules, including validation activities at scale, continued process verification and PQRs.

The role requires a chemistry degree, substantial experience in small molecule manufacturing with strong cGMP, and the ability to interact with internal teams and regulatory