QA CSV Engineer (m/f/d)

Randstad
Aubonne, Vaud, CH
Diese Stelle ist in deinem Land nicht verfügbar.

Jobdescription

Key Responsibilities

Contributeto CSV strategies, plans, and protocols in accordance withregulatory As a QA IT CSV Engineer, you will be responsible forensuring compliance for computerized systems and computerizedsystems validation, fulfill with regulatory requirements andoperate as intended.

Your primaryresponsibilities will include : guidelines (e.g., FDA 21 CFR Part 11,EU Annex 11, GAMP 5)

  • Contribute to riskassessments and participate to test scripts for computer systemvalidation activities
  • Supervise validationtesting, including Installation Qualification (IQ), OperationalQualification (OQ), and Performance Qualification(PQ)
  • Document validation activities, findings,deviations and CAPA in compliance with regulatoryrequirements
  • Conduct reviews and ensuresoftware development adheres to industry standards and bestpractices
  • Collaborate with cross-functionalteams, including Quality Assurance, IT, and subject matter experts,to ensure successful validation efforts

Functie-eisen

Required Qualifications

  • Bachelor's degree in Computer Science, Engineering, or a relatedtechnical field
  • Minimum of 4-7 years ofexperience in computer system validation or quality assurance roleswithin regulated industries
  • Comprehensiveknowledge of CSV regulations, guidelines, and industry standards(e.g., FDA, EMA, GAMP)
  • Proficiency invalidation methodologies, tools, and techniques (e.g., riskassessment, test script development, defectmanagement)
  • Strong analytical, problem-solving,and documentation skills
  • Excellentcommunication and interpersonal abilities for collaborating withcross-functional teams
  • Familiarity withsoftware development life cycles and quality assurancepractices
  • SAP S / 4 HANA (or different version)experience needed

PreferredQualifications

  • Experience with validation ofvarious computer systems (e.g., ERP, LIMS, MES, SDLCtools)
  • Knowledge of Agile and DevOpsmethodologies and their impact on validationactivities
  • French andEnglish
  • Vor einem Tag
Ähnliche Stellenangebote
Gesponsert
Randstad
Aubonne VD, Waadt

Contributeto CSV strategies, plans, and protocols in accordance withregulatory As a QA IT CSV Engineer, you will be responsible forensuring compliance for computerized systems and computerizedsystems validation, fulfill with regulatory requirements andoperate as intended. Bachelor's degree in Comput...

Randstad - Medium prio
Aubonne VD, Waadt

Contribute to CSV strategies, plans, and protocols in accordance with regulatory As a QA IT CSV Engineer, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfill with regulatory requirements and operate as intended. Bachelor's degree in C...

L.E.S.S. SA
Renens, Waadt

A rigorous and proactive Quality Engineer who will be responsible of efficient continuous improvement loops with regards to product quality, manufacturing processes and new project / technology development. As the quality Engineer you will inspect the parts and check their conformity with the s...

SIX Payment Services
Switzerland

You are a highly motivated, Certified test engineer (ISTQB)/ test managers. Support End2End Tests and User Acceptance tests with our customers (on site as well as online). Implement test automation for existing applications and maintain existing automatic tests. Agile mindset with strong customer fo...

EPM Scientific
Switzerland

Supporting Quality Engineers in ensuring the regulatory conformity of processes and products within the framework of quality assurance, taking into account the quality methods according to ISO 13485 and 21 CFR Parts 11 and 820. Supporting Quality Engineers in reviewing and approving the test strateg...

Fincons Group
CH

Tasks: Analysis of requirements and specifications for automated and manual tests Managing test cases and ensuring that requirements are adequately covered Evaluation and documentation of test results Execution of test cases (manual or automatic) and analysis of results Creation of test reports to d...

Michael Page Switzerland
Lausanne, Waadt

AsQuality Engineer you are the central quality contact for theorganisation. Leadthe Quality System of the organisation from design technology tomanufacturing process. Lead Quality System according toISO13485. Quality Management in medicaldevices, ideally with Class III. ...

Michael Page
International, CH

Electronics engineer or related technical education, you benefit from at least 5 years of quality engineering experience within the electronics field. Responsible for developing, implementing and maintaining the company Quality Management System. Regularly evaluate suppliers to ensure compliance wit...

Limula
Lausanne, Waadt

Quality Engineer (F/M, 80-100%). To support Limula in its mission to make Cell and Gene Therapies accessible to patients, you will support the Chief Operations Officer in the implementation and maintenance of the company quality management system (QMS), and perform and contribute to the quality rela...

Swissels Engineering & Life Science Services
Vaud, CH

Diplôme HES en technologie biomédicale, formation supérieure technique ou Bachelor en sciences.Ou au moins 5 ans d’expérience dans une fonction similaire, idéalement en environnement industriel.Familiarité avec les cadres normatifs de la santé (I...