L’opérateur de fabrication est capable de conduire un procédé ou une partie de procédé chimique et technologique en fonctionnement normal sous une étroite supervision. Il dispose de peu de liberté pour s’écarter des procédures établie. Il connait et respect les normes, directives et procédures liées à ses activités. Les responsabilités ci-dessous doivent être considérées dans un périmètre clairement défini, avec une étroite supervision et pour lesquelles une formation adéquate a été reçue. • Suivre la bonne marche technique, physique et chimique des installations ou d’une partie d’installation en fonctionnement normal, en respectant scrupuleusement les directives, exigences d’hygiène, de sécurité, d’écologie et de qualité (HSEQ). • Effectuer des charges et des vidanges de matière dans le cadre de procédures établies et pour lesquelles il a reçu la formation adéquate • Prélever les échantillons de matières solides liquides ou gazeuses dans des appareils, des installations et effectuer les analyses de routine. • Participer aux interventions, y compris avec les mécaniciens et électriciens, entreprises externes dans les travaux de maintenance.

Job Description Job Title: CSV & QA Compliance Specialist – Validation Assessment & Remediation Company: Inova (www.inova-sa.ch) Location: Basel Area, Switzerland Contract Type: Full-time – On-site About Inova Inova is a Swiss consulting and engineering firm specialized in supporting life sciences industries through high-value expertise in quality, compliance, engineering, and digital transformation. We partner with pharmaceutical and biotech companies to strengthen compliance, optimize validation strategies, and ensure operational excellence across regulated environments. Position Overview We are seeking a CSV & QA Compliance Specialist to support a pharmaceutical client in the Basel area with validation assessment, remediation activities, and quality oversight of computerized systems used across the organization. This role requires a hands-on CSV professional capable of autonomously conducting assessments of various GxP systems, evaluating historical validation documentation, identifying compliance gaps, and driving corrective actions in collaboration with QA, IT, Engineering, and business stakeholders. The ideal candidate combines strong technical CSV expertise with quality and compliance mindset, including deviation management, CAPAs, audit readiness, and change control activities within a GMP-regulated environment. Key Responsibilities Conduct autonomous CSV assessments of computerized systems across GxP environments Evaluate validation status and compliance of systems used in manufacturing, laboratories, QA, and business operations Review historical validation documentation and identify remediation or corrective actions Assess executed test scripts and coordinate test review and re-execution when required Support and manage deviations, investigations, and CAPA activities linked to CSV compliance gaps Participate in and support Change Control activities related to computerized systems Ensure alignment with GAMP 5, Annex 11, 21 CFR Part 11, and data integrity requirements Collaborate cross-functionally with QA, IT, Engineering, and system owners Contribute to audit readiness activities and support internal and external inspections Provide risk-based recommendations for validation lifecycle improvements Support continuous improvement initiatives related to CSV and compliance processes Why Join Inova? Join impactful pharmaceutical compliance and digital quality projects Work on diverse GxP systems and complex validation environments Be part of a collaborative and highly specialized consulting team Contribute to quality excellence and compliance strategy within leading life sciences organizations Grow within a company that values expertise, autonomy, and innovation How to Apply Send your application to careers@inova-sa.ch Subject line: CSV & QA Compliance Specialist – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.

Job Description Job Title: Qualification Specialist – Manufacturing Support Company: Inova (www.inova-sa.ch) Location: Lausanne Area, Switzerland Contract Type: Full-time – On-site About Inova: Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in quality, compliance, and digital transformation. We help our clients build robust, future-proof quality systems, from shopfloor execution to enterprise-level governance. Position Overview: We are looking for a Qualification Specialist with a strong generalist background to support manufacturing operations for a leading pharmaceutical client in the Basel area. This role focuses on equipment and utilities qualification across a wide range of systems, including laboratory and production environments (biotech, pharma, and chemical). A significant portion of the activities will involve periodic qualification of utilities, ensuring compliance, performance, and reliability over time. The position requires autonomy, organizational skills, and the ability to define and lead qualification strategies while collaborating with cross-functional teams in a GMP-regulated environment. Key Responsibilities: Execute qualification activities (IQ, OQ, PQ) for production and laboratory equipment Lead initial and re-qualification of equipment across biotech, pharma, and chemical environments Perform and manage periodic qualification of utilities (e.g., HVAC systems, gas networks) Contribute to and define qualification strategies aligned with site and regulatory requirements Support qualification of SIP cycles where applicable Ensure proper documentation in compliance with GMP standards Coordinate with Manufacturing, Engineering, QA, and other stakeholders Plan, organize, and manage qualification activities autonomously Support continuous improvement initiatives within qualification processes Ensure alignment with client culture, values, and operational excellence standards Profile Requirements: Engineering degree or equivalent scientific background Minimum 3 years of experience in qualification within GMP environments Strong hands-on experience with IQ, OQ, and PQ execution Proven experience in qualification of production and laboratory equipment Generalist mindset with the ability to handle diverse systems and environments Experience with SIP cycle qualification is a plus Experience in periodic qualification of utilities (HVAC, gas systems) strongly preferred Ability to define and lead qualification strategies Autonomous, well-organized, and proactive Fluent in French (mandatory) with good understanding of English Willingness to work on-site in the Lausanne area (100% position) Why Join Inova? Work on diverse qualification projects across multiple technologies and environments Play a key role in maintaining compliance and operational excellence in manufacturing Join a dynamic and collaborative team within a leading life sciences hub Contribute to high-impact projects in a GMP-regulated setting How to Apply: Send your application to careers@inova-sa.ch Subject line: Qualification Specialist – Basel Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.