Csv Specialist

3 settimane fa

Monza, Italia amaris A tempo pieno

Job description

Join the Amaris Consulting talent network as a CSV Specialist in the Pharmaceutical sector in Monza

What will you do?

Perform computer system validation activities, including planning, executing, and documenting validation protocols, test scripts, and reports in compliance with regulatory guidelines (such as FDA 21 CFR Part 11, EU Annex 11) and internal policies.
Coordinate and execute risk assessments for computerized systems to identify potential areas of non-compliance and develop appropriate mitigation strategies.
Collaborate with cross-functional teams, such as IT, Quality Assurance, and Manufacturing, to define validation requirements, develop validation plans, and ensure timely completion of validation activities.
Review and assess system change requests, assess their impact on validated systems, and provide guidance on the necessary validation activities to maintain compliance.
Develop and maintain standard operating procedures (SOPs) related to computer system validation, change control, and electronic systems in accordance with regulatory requirements.
Support audits and inspections by regulatory agencies and internal quality audits, ensuring all validation documentation is up-to-date and readily accessible.
Provide training and guidance to personnel involved in computer system validation to enhance their understanding of validation principles and compliance requirements.
Participate in continuous improvement initiatives, contributing to the development and implementation of best practices, tools, and templates for computer system validation.

✍️ What do we request?

Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field. Relevant certifications (such as CSV, GAMP) are a plus.
Minimum of 3 years of experience in computer system validation within the pharmaceutical industry, with a strong focus on handling validation documents, procedures, change control, and electronic systems.
Deep understanding of regulatory requirements and guidelines applicable to computer system validation, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP.
Experience with various computerized systems used in the pharmaceutical industry, such as manufacturing execution systems (MES), laboratory information management systems (LIMS), and document management systems (DMS).
Knowledge of data integrity principles and practices, including audit trails, electronic signatures, and data backup and restoration processes.
Familiarity with validation approaches for cloud-based systems and software as a service (SaaS) solutions would be beneficial.
Strong analytical and problem-solving skills, with the ability to identify and resolve validation issues effectively.
Excellent written and verbal communication skills, with the ability to communicate complex technical concepts to both technical and non-technical stakeholders.
Detail-oriented with a high level of accuracy and the ability to manage multiple tasks and deadlines concurrently.
Experience working in a regulated environment, such as GMP or ISO 13485, is highly desirable.

✨ What do we offer?

Work by objectives with quarterly monitoring.
Educational and technical growth path.
Inclusive work climate.
Lunch vouchers of €8 per working day.
Free access to Mantu Academy platform with more than 500 courses.
Free access to Udemy platform with more than 200,000 courses.
Psychological counselling.

**Pioneer Spirit**: desire to explore new technologies, ideas, and skills to build a more sustainable world.

**Care**: commitment to promoting diversity, meritocracy, and environmental protection for a better future.

**Performance**: constant ambition to achieve excellence through creativity, innovation, and technology.

**Trust**: trust is a pillar of progress, driving freedom, creativity, and innovation.

**Independence**: independence is the basis for realizing a prosperous and agile future.

Amaris Consulting is an industry-leading Top Employer 2023-certified company that supports its partners in the main areas for Pharma and Biomed Industries in Quality, Laboratories, R&D and Production.

Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 6000 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn

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