QA CSV Remediation Specialist – On-Site, Switzerland

Inova Consulting; Basel; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Inova is seeking two QA Specialists, CSV Remediation, to support a pharmaceutical site in Switzerland preparing for Swissmedic inspection. You will oversee remediation findings across MES, SCADA, and shop‑floor applications, ensuring a complete, inspection‑ready documentation package. You will supervise testing activities rather than perform them, collaborating with system teams and site QA governance as it develops.

Fluent English required; French not required; start ASAP.

Qualifikationen

• Minimum 5 years of QA and/or CSV experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Strong experience with manufacturing and production systems such as MES, SCADA, Factory Layer, automation platforms, or comparable shop‑floor systems.
• Solid understanding of GxP requirements, computerized system validation, data integrity, and the system lifecycle.
• Ability to operate effectively in an environment where quality governance and procedures are still being developed.
• Fluent English is required; French is not required.

Aufgaben

• Review and remediate findings identified during internal assessments of manufacturing and automation systems.
• Define pragmatic remediation priorities based on compliance risk, inspection readiness, and operational feasibility.
• Resolve immediately actionable gaps in collaboration with system, automation, IT, and manufacturing teams.
• Identify, justify, and formally document remediation items that depend on broader site QA governance or future procedural decisions.
• Build a complete, inspection‑ready documentation package for each assigned production system.
• Ensure that each system package can be presented clearly and independently during the Swissmedic inspection.
• Provide QA oversight of testing activities performed by system and technical teams.
• Review and approve validation protocols, test evidence, reports, deviations, and supporting documentation.
• Verify that remediation activities comply with applicable GxP, CSV, data integrity, and quality requirements.
• Support the preparation of system owners and technical teams for inspection‑related discussions.
• Track remediation progress, elevate risks, and ensure delivery against inspection deadlines.
• Collaborate closely with QA, Manufacturing, Automation, IT, Engineering, and System Owners.

Kenntnisse

QA/CSV experience

MES/SCADA/Factory Layer experience

GxP data integrity knowledge

Fluent English

Risk-based, pragmatic mindset

Ausbildung

Bachelor's degree in Life Sciences, Engineering, Computer Science, Automation or related discipline

Jobbeschreibung

Inova is seeking two QA Specialists, CSV Remediation, to support a pharmaceutical site in Switzerland preparing for Swissmedic inspection. You will oversee remediation findings across MES, SCADA, and shop‑floor applications, ensuring a complete, inspection‑ready documentation package. You will supervise testing activities rather than perform them, collaborating with system teams and site QA governance as it develops.

Fluent English required; French not required; start ASAP.