CSV Validation Specialist
vor 2 Monaten
At Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.
Key Responsibilities- Provide input on the improvement of testing documentation to ensure compliance with regulatory requirements.
- Support the implementation and adoption of our global CSV program and remediation efforts.
- Collaborate with IT and Site organizations to ensure that Computerized System Validation packages are consistent with validation plans and standard operating procedures.
- Participate in audits and continuous improvement efforts to maintain a high level of quality and compliance.
- Master's Degree or Bachelor's degree in Computer Science, Life Sciences, Engineering, Biotechnology, or Automation.
- At least 10 years of experience in CSV in the Pharma or Biotech industry.
- Great understanding of CSV regulations such as FDA's 21 CFR Part 11 and EMA's Annex 11.
- Experience in modern and risk-based validation executions.
- Background in Pharma/Biotech industries.
- Direct experience with LIMS or Laboratory systems is a plus.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced CSV Validation Specialist looking for a new challenge, please submit your application.
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CSV Validation Specialist
vor 1 Monat
Bern, Bern, Schweiz Consultys VollzeitJob DescriptionAt Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.Key Responsibilities:Provide input on the improvement of testing documentation to ensure compliance...
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CSV Validation Specialist
vor 1 Monat
Bern, Bern, Schweiz Consultys VollzeitJob Title: CSV Validation SpecialistAt Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.Key Responsibilities:Provide input on the improvement of testing documentation to...
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