IT Compliance Specialist at Thermo Fisher Scientific

Ferentino, Latium, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, PharmaceuticalsIndustries

Requirements

Master’s or bachelor’s degree required (Information Technology, Computer Science, Engineering or Science related fields)
Proven ability in IT or CSV, preferably within the pharmaceutical or life sciences industry
Demonstrable knowledge of IT controls, GAMP5, GxP regulations, CSV, SDLC, Data Integrity, Part 11, Annex11, and relevant standards
Strong analytical, prioritization, problem-solving, time management and organization skills
Excellent written, verbal communication and interpersonal skills to effectively collaborate with multi-functional global/local teams and end-users
Shown flexibility to balance and prioritize numerous tasks
Drive and desire to learn and grow both technical and functional skills
Participate in industry / functional area groups / forums and integrate / implement new lessons learned
Proficient Italian and English
Highly oriented to collaborate between teams
Critical thinking, pragmatic and oriented to prioritization and results achievement
Strong analytical and problem-solving skills and the capability to work accurately on multiple projects
Self-motivated with the ability to work autonomously in a fast-paced environment
Ability to efficiently learn and seek new business domains and problems
Intellectual curiosity to understand and answer questions with ability to collaborate with multiple business partners and bringing innovative solutions

Responsibilities

Coordinate with the Computer System Validation team and Quality Assurance to ensure IT Quality Standards are met in accordance with local SOPs and cGMP requirements
Deliver solutions and support in collaboration with local and global functions, providing operational compliance and technical support to the site to drive efficient and compliant technology solutions
Serve as IT point of contact during systems validation, supporting testing activities performed by CSV team
Ensure that systems validation status is accurately maintained after release, according to internal and industry regulations
Ensure the refresh of IT operating procedures, periodicals reviews in partnership with the IT technical/application group and CSV
Ensure that the documentation provided by the suppliers aligns with internal quality standards
Develop and implement test plans, document business processes, requirements, system technical specs, and project requirements needed to support business procedures and regulations
Lead, implement and participate in multiple projects by completing and updating project documentation; leading project scope; adjusting schedules when needed; resolving daily priorities; addressing blocking issues; managing customer and supplier relationships, and ensure project completion on time, within scope and within budget
Maintains and performs periodic user reviews of main IT systems
Support clients or regulatory inspections (internal, external including FDA & AIFA) and implement corrective actions as appropriate
Proactively identify and anticipate issues to deliver the expected IT activities to meet compliance expectations and get alignment with the corresponding Guidance and Corporate Standards
Support the IT functions in the gap analyses versus the GMP regulations updating and new guidelines requests; contribute to the related plan elaboration, including the definition and monitoring of the proper corrective actions to ensure GMP site compliance
Support the site Regulatory Inspections readiness in order to assure that each inspection is properly handled
Guide the periodic discussion on IT internal metrics sharing and supervising performance
Ensure that the IT systems are maintained in the appropriate state of compliance and are suitable to be used for their intended purpose

Skills

IT Compliance

Computer System Validation

cGMP

SOPs

Quality Assurance

Systems Validation

Test Plans

Project Management

FDA Inspections

Gap Analysis

Regulatory Compliance

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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