Head of DSP Manufacturing & Validation (QA)

GXP CONSULTING Switzerland; Mittelwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a QA Validation Manager to ensure robustness and GMP compliance of critical processes. You’ll act as a key link between MSAT, Manufacturing and the client, delivering sound, well-documented evidence of process control.

Drive validation of biotechnological processes in a low-bioburden environment, oversee qualification of equipment and cleaning, ensure CPV, and support audits by European authorities and FDA. Fluent English is required; German is a plus.

Qualifikationen

• Bachelor's degree in Science, Biotechnology, or a related field.
• 5–7 years of experience in the pharmaceutical industry within a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment/system qualification.
• Experience with change controls, deviation management, and non-conformity investigations.
• Understanding of cell & gene manufacturing processes and low-bioburden environments.
• Fluent English required; German is a plus.

Aufgaben

• Drive validation of biotechnological processes in a low-bioburden (cell & gene) environment.
• Oversee qualification of related equipment and systems, as well as validation of manual and automated cleaning/sanitization processes.
• Ensure ongoing continuous process verification (CPV) and ownership of validation activities.
• Serve as the go-to QA contact for product transfer projects and related validation strategy.
• Carry out change control and deviation impact assessments, and support non-conformity investigations.
• Review and approve GMP documentation: protocols, reports, SOPs, change controls, deviations (process validation, cleaning, CSV).
• Act as subject matter expert for SOPs covering process and cleaning validation.
• Take part in audits and inspections (European authorities and FDA).
• Contribute to continuous improvement initiatives and the data integrity program.
• Participate in risk assessments.

Kenntnisse

Fluent English

German (nice to have)

Ausbildung

Bachelor's degree in Science/Biology/Biotech

Jobbeschreibung

GXP CONSULTING Switzerland is seeking a QA Validation Manager to ensure robustness and GMP compliance of critical processes. You’ll act as a key link between MSAT, Manufacturing and the client, delivering sound, well-documented evidence of process control.

Drive validation of biotechnological processes in a low-bioburden environment, oversee qualification of equipment and cleaning, ensure CPV, and support audits by European authorities and FDA. Fluent English is required; German is a plus.