Computerized Systems Validation (CSV) Specialist/Engineer/An …, Oss
Computerized Systems Validation (CSV) Specialist/Engineer/An …, Oss
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5340 Oss, Nederland -
Geplaatst op: minder dan een maand geleden
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Onthouden -
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Advertentietekst
As part of the Corporate CSV team, the CSV Specialist/Engineer/Analyst will be responsible for validating all GxP-compliant computerized systems within Ardena.
Key Responsibilities
Take part in setting up and documenting a risk-based validation strategy.
Draw up validation project plans and validation documents according to international GxP guidelines.
Review current procedures and adjust or rewrite where necessary.
Ensure that data integrity requirements are met.
Stay informed about emerging validation regulations and testing practices.
Provide technical assistance related to current US FDA and EU validation requirements.
Monitor compliance with relevant regulations such as CFR 21 Part 11 / Annex 11.
Determine the impact of changes and draw up deviations and CAPAs.
Collaborate closely with QA, IT, validation engineers and other departments.
Profile
Bachelor’s degree in a scientific direction (Chemistry, Chemical Engineering, Biotechnology, Pharmacy, IT) or comparable level through experience.
At least 5 years of experience in Health&Life sciences, pharmaceutical or food/nutrition industry.
Experience with GxP, GAMP5, 21CFR Part 11, ISO and related terms such as QMS, Data integrity, CAPA, LIMS, CDS.
Ability to advise and solve validation problems related to projects, process development, risk mitigation, etc.
Willingness and ability to travel up to 20% of the time to support local teams.
Comfortable in a dynamic and changing environment.
Eagerness to learn and develop professionally.
Flexible, a problem solver and a team player.
Accurate and analytical mindset.
Interest in AI.
Good communication skills in English (written and spoken).
Knowledge of Dutch and Spanish is beneficial.
What We Offer
Competitive salary.
Flexible working hours.
Dynamic, international work environment with career growth opportunities.
Access to Ardena Academy, an internal learning platform for professional development.
Opportunity to contribute to groundbreaking drug development projects.
#J-18808-Ljbffr
Key Responsibilities
Take part in setting up and documenting a risk-based validation strategy.
Draw up validation project plans and validation documents according to international GxP guidelines.
Review current procedures and adjust or rewrite where necessary.
Ensure that data integrity requirements are met.
Stay informed about emerging validation regulations and testing practices.
Provide technical assistance related to current US FDA and EU validation requirements.
Monitor compliance with relevant regulations such as CFR 21 Part 11 / Annex 11.
Determine the impact of changes and draw up deviations and CAPAs.
Collaborate closely with QA, IT, validation engineers and other departments.
Profile
Bachelor’s degree in a scientific direction (Chemistry, Chemical Engineering, Biotechnology, Pharmacy, IT) or comparable level through experience.
At least 5 years of experience in Health&Life sciences, pharmaceutical or food/nutrition industry.
Experience with GxP, GAMP5, 21CFR Part 11, ISO and related terms such as QMS, Data integrity, CAPA, LIMS, CDS.
Ability to advise and solve validation problems related to projects, process development, risk mitigation, etc.
Willingness and ability to travel up to 20% of the time to support local teams.
Comfortable in a dynamic and changing environment.
Eagerness to learn and develop professionally.
Flexible, a problem solver and a team player.
Accurate and analytical mindset.
Interest in AI.
Good communication skills in English (written and spoken).
Knowledge of Dutch and Spanish is beneficial.
What We Offer
Competitive salary.
Flexible working hours.
Dynamic, international work environment with career growth opportunities.
Access to Ardena Academy, an internal learning platform for professional development.
Opportunity to contribute to groundbreaking drug development projects.
#J-18808-Ljbffr
Belangrijke informatie
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BedrijfsnaamArdena Careers -
PositieComputerized Systems Validation (CSV) Specialist/Engineer/Analyst
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Melden -
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