QA CSV Specialist

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

QA Specialist – CSV Remediation

Job Title: QA Specialist – CSV Remediation

Company: Inova (www.inova-sa.ch)

Location: Switzerland

Contract Type: Full-time, On‑site

Open Positions: 2

Start Date: ASAP

About Inova

Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high‑value expertise in quality, compliance, engineering, and digital transformation. We help our clients strengthen their operational capabilities and build robust, inspection‑ready quality systems across manufacturing environments.

Position Overview

We are seeking two experienced QA Specialists, CSV Remediation to support a pharmaceutical manufacturing site preparing for an upcoming Swissmedic inspection.

Recent assessments have identified compliance and validation gaps across several production and automation systems, including MES, SCADA, Factory Layer, and related shop‑floor applications. Your role will be to provide QA oversight and drive the remediation of these findings, ensuring that each system is supported by a clear, complete, and inspection‑ready documentation package.

This assignment requires a strong QA and CSV background combined with a pragmatic approach. You will need to distinguish between issues that can be resolved immediately and those that depend on site‑level QA governance that is still under development.

This is a QA oversight position. You will supervise, review, and approve testing activities performed by the relevant system teams rather than execute testing directly.

Key Responsibilities

• 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

Profile Requirements

• Degree in Life Sciences, Engineering, Computer Science, Automation, or a related discipline
• Minimum 5 years of experience in QA and/or CSV within 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
• Experience reviewing and approving validation documentation and test evidence from a QA perspective
• Ability to operate effectively in an environment where quality governance and procedures are still being developed
• Strong QA mindset combined with a pragmatic, risk‑based approach
• Experience supporting a new production line, greenfield facility, or site start‑up is highly desirable
• Autonomous, structured, and delivery‑oriented working style
• Ability to manage multiple systems and remediation workstreams simultaneously
• Strong stakeholder management and communication skills
• Fluent English required
• French is not required

Why Join Inova?

• Contribute directly to the inspection readiness of a pharmaceutical manufacturing site
• Take ownership of high‑impact CSV remediation activities across critical production systems
• Work at the intersection of QA, manufacturing, automation, and digital systems
• Apply your expertise in a pragmatic environment with clear delivery objectives
• Join a dynamic team that values autonomy, precision, collaboration, and accountability

Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.