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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr
QA CSV Specialist Arbeitgeber: Inova Consulting
Inova ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, eine Schlüsselrolle in strategischen Industrieintegrationsprojekten zu übernehmen. Mit einem Fokus auf Präzision, Autonomie und Zusammenarbeit fördert Inova eine positive Arbeitskultur, in der Sie mit erfahrenen Projekt-, Ingenieur-, Automatisierungs- und Qualitätsteams zusammenarbeiten können. Zudem profitieren Sie von umfangreichen Entwicklungsmöglichkeiten in einem dynamischen Umfeld, das sich auf die Zukunft der Lebenswissenschaften und Industrie konzentriert.
