IT Compliance Specialist

Work ScheduleStandard Office Hours (40/wk)

Environmental ConditionsOffice

Job Description

As IT Compliance Specialist you will 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. As a member of the PSG IT Team, will 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.

Assignments, specific/primary activities:

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.

Ensuring 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.

Education and Professional background:

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.

Technical skills:

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.

Languages:

Proficient Italian and English.

Personality Traits:

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.

R-01328996