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Data Integrity & Computerized Systems Validation Lead Europe

Sharp Clinical Services -
Heerenveen

Nu solliciteren

Vacaturegegevens

Fulltime

Secundaire arbeidsvoorwaarden

Auto van de zaak
Pensioen

Kwalificaties

Engels
Microsoft Office
Master
Analytisch vermogen
Leidinggevende ervaring
Bachelor

Volledige vacaturetekst

Sharp is a global leader in pharmaceutical packaging, with operations across the US, UK, the Netherlands, and Belgium. Our sites in Heerenveen and Hamont-Achel specialize in commercial labeling and packaging services, supporting customers throughout the product lifecycle.

At Sharp, you will join a growing international team of approximately 380 professionals, all committed to enhancing patients’ quality of life. Our facilities offer over 20,000 m² of GMP-compliant packaging space, combined with deep expertise in packaging design, serialization, Qualified Person (QP) market release, and artwork services.

We place our customers at the center of everything we do, delivering flexible, tailored solutions to meet complex and evolving needs.

To further strengthen our team, we are currently recruiting for a:

Data Integrity & Computerized Systems Validation Lead Europe

Are you passionate about ensuring data integrity and compliance in a highly regulated environment?

As Data Integrity & CSV Lead, you will be responsible for safeguarding the integrity, compliance, and validation status of all GxP-relevant data and computerized systems across our sites in the Netherlands, Belgium, and Wales.

You will define and maintain the Data Integrity framework and Computerized System Validation (CSV) strategy, ensuring compliance with ALCOA++, EU GMP Annex 11, Chapter 4, 21 CFR Part 11, and GAMP 5 requirements.

Key responsibilities

Establish and maintain harmonized Data Integrity and CSV frameworks across Europe sites
Own DI and CSV policies, procedures, and standards aligned with global requirements
Maintain oversight of DI and validation status of all GxP computerized systems
Ensure systems remain in a validated state and changes are assessed through CSV and DI lens
Lead and standardize DI and CSV risk assessments (including system and process risks)
Ensure controls across full data lifecycle and system lifecycle (validation lifecycle)
Partner with IT/Engineering to ensure system controls (audit trails, access, backup, interfaces) meet DI requirements
Review and approve validation deliverables (URS, risk assessments, IQ/OQ/PQ, reports) from a DI/CSV perspective
Ensure DI and CSV requirements are embedded in validation, change control, deviations, and CAPA processes
Act as SME during audits/inspections for both Data Integrity and CSV
Drive inspection readiness and remediation of findings related to DI and CSV
Define and deliver training strategy for DI and CSV across Europe sites
Lead continuous improvement and harmonization initiatives across sites
Lead and execute Data Integrity and CSV remediation activities, including gap assessments, root cause analysis, and implementation of corrective and preventive actions across EU sites.
Develop, update, and author DI and CSV deliverables, including risk assessments, procedural updates, validation documentation (URS, protocols, reports), and remediation plans.

Profile

Preferably a Master's or Bachelor's degree in IT, minimum HBO (higher professional education) working and thinking level
Significant experience in GMP-regulated environment
Experience with setting up and supervising CSV or other validation studies is a plus.
Strong experience in Data Integrity and Computerized System Validation (CSV)
Knowledge of GAMP5, EU GMP, Annex 11, Chapter 4, 21 CFR Part 11, ALCOA++
Experience with validation lifecycle (URS, IQ/OQ/PQ, continued validation)
Experience with quality systems, procedures, training, etc.
Experience with multi-site quality oversight is a plus
Proficient in MS Office
Good knowledge of English and Dutch (written and spoken)
Experience in writing reports
Strong ownership and accountability
Ability to influence without direct authority
Analytical and risk-based thinking
Strong communication and stakeholder management
Strategic and operational balance
Continuous improvement mindset
Able to organize tasks independently and set the right priorities, as well as work in a team.
Willing to travel to Sharp Netherlands, Belgium, and Wales locations for short periods (depending on the location)

Offer

At Sharp, we strive to create a work environment where all employees can maximize their potential. We offer a versatile and challenging position in a dynamic workplace, with numerous career development opportunities. You can expect a suitable salary package, supplemented with a range of benefits, such as:

A full-time position with diverse responsibilities
Company Car
Work-from-home allowance
Bike leasing option
Pension plan

Interested?

Apply with your CV and cover letter | Contact: Paul de Lange | [email protected]| +31 6 27239309 |

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it manager vacatures in heerenveen, fr

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