Senior QA Specialist - GMP & Sterile Ops

Lonza Group Ltd.

Stein

Hybrid

Confidential

Full time

6 days ago

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Job summary

Lonza Group Ltd. in Stein (AG), Switzerland seeks an experienced QA professional to provide oversight for shopfloor manufacturing activities within a growth project, ensuring GMP compliance and operational readiness.

You will review SOPs and other GMP documents, partnering with Manufacturing to drive aseptic process readiness and support audits. The role requires hands-on shopfloor involvement and proactive quality leadership.

Qualifications

Pharma industry experience in GMP-regulated environment.
Experience with deviations, CAPAs and investigations.
Fluent English and German communication.
Willingness to spend significant time on the shopfloor in aseptic gowning.
Degree in Life Sciences, Pharmacy, Chemistry, Biology or related field.

Responsibilities

Provide QA oversight for shopfloor manufacturing activities within an exciting growth project, ensuring GMP compliance and operational readiness.
Review and approve SOPs, work instructions and other GMP documentation to support start-up and sustainable manufacturing operations.
Partner with Manufacturing teams to drive aseptic process readiness including training support and execution readiness for APS and future media fill activities.
Lead and coordinate quality events by reviewing and approving deviations, CAPAs, investigations, and related quality records.
Act as the Quality representative during project discussions, audits, and inspections and support inspection readiness.