CSV Specialist
CSV Specialist
Posted on :
27-06-2025
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1 Vacancy
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Job Description
As the CSV (Computer System Validation) Specialist you will report directly to the CSV Manager and be the subject matter expert responsible for running CSV activities in Gnosis BU.
Main responsibilities:
- Championing full lifecycle validation for all applicable computerized systems ensuring they are designed validated operated and retired in compliance with GMP regulation and computer system validation (CSV) guidance.
- Support the periodic review of software applications used in GMP processes including those for quality control production and supply chain.
- Collaborate with cross-functional departments (QA IT Production QC) to ensure that systems are compliant and fit for purpose.
- Prepare review and maintain validation documentation: URS FRS Risk Assessments IQ/OQ/PQ Protocols Traceability Matrices and Summary Reports.
- Support the change control process assessing the validation impact of changes to GMP systems.
- Act as a subject matter expert (SME) during audits and inspections providing documentation and evidence related to system validation and compliance.
- Working with system vendors to leverage appropriate information and documentation into CSV activities.
- Coordinate and oversee the activities of external consultants involved in CSV projects.
- Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety product quality and data integrity.
- Provide first-line support and training to end-users on GMP-relevant applications ensuring proper use and adherence to procedures.
- In collaboration with the IT Dept. act as system administrator for local GMP-relevant applications e.g. Laboratory systems eQMS.
Qualifications :
- 35 years of experience in a CSV role within a GMP-regulated pharmaceutical environment. Experience in API manufacturing is a plus.
- Bachelors or Masters degree in Life Sciences Engineering Computer Science or a related field.
- Knowledge of GAMP 5 PIC/S guidance and general validation principles.
- Strong understanding of FDA EU and other governing bodies regulations and requirements for GMP including FDA 21 CFR Part 11 EU Annex 11.
- Knowledge of data integrity and data governance (ALCOA principles)
- Good understanding of client-server architecture databases (e.g. Oracle SQL Server) and network concepts
- Proficiency with Windows Server and Windows OS environments
- Knowledge of typical GMP software (e.g. ERP. MES. LIMS CDS Laboratory Systems)
- Good documentation and communication skills.
- Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams including QA IT and external vendors
- Strong analytical and problem-solving mindset.
- Professional working proficiency in English
Additional Information :
- The job is based in Desio (MB) - Italy
- Full-time contract
- Possible Smart-Working after trial period
- Be part of a growing company
- Work in a dynamic international environment
- We are a successful family-owned company with long-standing history where people truly matter.
- We promote a sense of fulfilment with a genuine mission: nourish and protect the planet.
- An opportunity to work in a real international environment.
At Lesaffre diversity is a strength that enriches our culture and our teams. We are committed to offering you a work environment where you can thrive regardless of your background gender age or abilities. We encourage all applications as we believe that diverse perspectives strengthen our ability to innovate and meet the challenges of tomorrow.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
Key Skills
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