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 the 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 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 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 change control processes by assessing the validation impact of changes to GMP systems.
* Act as a SME during audits and inspections, providing documentation and evidence related to system validation and compliance.
* Work with system vendors to incorporate relevant information and documentation into CSV activities.
* Coordinate and oversee external consultants involved in CSV projects.
* Work with process owners to identify, implement, and upgrade systems to improve 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.
* Collaborate with the IT department to act as system administrator for local GMP-relevant applications (e.g., Laboratory systems, eQMS).
Qualifications :
* At least 3-5 years of experience in a CSV role within a GMP-regulated pharmaceutical environment. Experience in API manufacturing is a plus.
* Bachelor's or Master's 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 regulatory requirements for GMP, including FDA 21 CFR Part 11 and EU Annex 11.
* Knowledge of data integrity and data governance principles (ALCOA).
* Understanding of client-server architecture, databases (e.g., Oracle, SQL Server), and network concepts.
* Proficiency with Windows Server and Windows OS environments.
* Knowledge of GMP software such as ERP, MES, LIMS, CDS, Laboratory Systems.
* Good documentation and communication skills.
* Strong interpersonal skills and ability to collaborate with cross-functional teams and external vendors.
* Analytical and problem-solving skills.
* Professional proficiency in English.
Additional Information :
* Location: Desio (MB), Italy
* Full-time contract
* Possible remote work after the trial period
* Opportunity to be part of a growing, dynamic international company
* We are a family-owned company with a focus on sustainability and employee well-being
We value diversity and are committed to providing an inclusive work environment for all applicants.
Remote Work : Employment Type : Full-time
Key Skills :
CSV, GMP, Validation, Compliance, Documentation, Cross-functional Collaboration, Regulatory Knowledge
Experience : 3-5 years
Vacancy : 1
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