(senior) Consultant For Csv Pharma/medical
Schweiz, Switzerland
Job Description
\\n Role: (Senior) CSV Consultant in Pharma and Medical
Full-time / Part-time
Location: either Zurich, Bern, Basel or Lausanne
Continued growth in digitalisation and increasing regulatory challenges are hot topics in the pharma/medtech industry.
Our client is a reputable IT management consultancy and they\\xe2\\x80\\x99re looking for professionals in the CSV area to be part of the team.
Tasks and Responsibilities
Full-time / Part-time
Location: either Zurich, Bern, Basel or Lausanne
Continued growth in digitalisation and increasing regulatory challenges are hot topics in the pharma/medtech industry.
Our client is a reputable IT management consultancy and they\\xe2\\x80\\x99re looking for professionals in the CSV area to be part of the team.
Tasks and Responsibilities
- Assisting pharmaceutical/medical sector clients in creating validation plans and project reports in collaboration with the team.
- Conducting and documenting risk analyses and FMEAs, preparing CSV/qualification documents, and ensuring proper filing in the document management system.
- Coordinating requirements with other departments and clients, working closely with project managers, the quality department, and stakeholders.
- Handling validation tasks, offering support on validation and qualification issues, and contributing to projects related to regulatory compliance, risk management, audits, and governance.
- University degree in compliance, risk management, or quality management, or show a keen interest in continuing education in these areas.
- You demonstrate experience in validating and qualifying computer systems within highly regulated industries.
- You have a deep understanding of guidelines and regulations such as CSV, GxP, EU GMP Annex 11, CFR 21 Part 11, and GAMP5.
- You can communicate complex solutions effectively in both German and English.
\\n\\n Sejelas\\n \\n\\n
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Job Detail
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Job IdJD1608800
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSchweiz, Switzerland
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EducationNot mentioned