QA & CSV Officer

Northern Italy (Homebased or Office Based in Verona)
QA & CSV

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QA & CSV Officer

Job Department: QA & CSV

Location: Northern Italy (Homebased or Office Based in Verona)

Contract details: Permanent, Full Time

Contact: hrarithmos@arithmostech.com

Position Description:

The purpose of this role, from a QA perspective, is to ensure compliance of Company’s Integrated Management System (Quality Management System and Information Security Management System) with respect to regulations and guidelines and its continuous improvement under QA & CSV Manager’s oversight. From a CSV perspective, the purpose of this role is to ensure that computer systems are properly validated and maintained in a compliance status, through appropriate change control management and periodic review, under QA & CSV Manager’s oversight.

Principal responsibilities include:

Principal responsibilities for this position include:

  • Management of the in-house bookkeeping and financial accounting system for all companies and territories part of Arithmos and other PM Holding companies
  • Collaborate with the QA & CSV Manager to ensure IMS maintenance and development to guarantee
    its efficiency and audit/inspection readiness
  • Manage clients’ complaints from the receiving to the closure, in cooperation with Line Managers
  • Oversee the deviation and incident management process from the registration through the analysis, action definition and closure
  • Oversee the CAPA management process
  • Support the QA & CSV Manager in preparation and management of internal, client and supplier audit, and in preparing detailed reporting on the audit results
  • Manage ISM documents, organizing and managing the Archive Facilities applying quality principles of archiving (as Archive Manager) in cooperation with the QA & CSV Manager
  • Manage suppliers’ qualification in cooperation with the other company functions
  • Act as trainer in your area of responsibility/expertise
  • Cooperate with QA & CSV Manager and relevant stakeholders for the validation of information systems, by managing and coordinating the drafting of Validation Plans, User Requirement Specifications, Functional and Design Specifications, Testing Protocols (IQ / OQ / PQ), User Acceptance Testing, Traceability Matrix and Validation Reports.
  • Support and monitor the correct management of Change Control of information systems
  • Cooperate with QA & CSV Manager and relevant stakeholders for the maintenance of the validation status of managed systems by implementing the Periodic Review procedures
  • Support resolution of system deviations/errors and management of CAPAs related to information systems in accordance with quality requirements and GxP
  • Ensure that the systems comply with regulatory requirements
  • Participate in the audits relative to Computer System Validation
  • Conduct trainings in Computer System Validation area
  • Collaborate in the definition of CSV SOPs, WIs, guidelines and best practices

Ideal Candidate Profile:

You are the one we are looking for if you have:

  • Degree in Economia & Commercio or Economia Aziendale or equivalent with at least 3 years’ experience in an equivalent position
  • Bachelor’s degree in technical/scientific subjects and at least 2 years of experience as QA and/or CSV specialist in Life Sciences industry
  • Knowledge of CSV regulations and guidelines (21CFR part 11, Annex 11, GAMP5)
  • Knowledge of pharma processes and GxP regulations (mainly GCP, GVP)
  • Knowledge of risk management principles
  • Basic Knowledge of ISO/IEC 27001:2013 and of ISO 9001:2015 Legislation
  • Basic Knowledge of computer information requirements legislation (privacy regulations)
  • Good written and spoken English
  • Problem Solving
  • Quality Philosophy
  • Flexibility
  • Initiative
  • Communication skills
  • Ability to work in a team
  • Time Management skills
  • Presentation skills

About Arithmos:

At Arithmos, our mission is to support our clients in embracing digital transformation that allows them to develop therapeutics for patients in a smart, innovative, and cost-efficient manner.

We are industry leading experts who combine the knowledge of processes and technologies to exceed the needs of our clients in the Life Science industry.

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