Data Integrity & Computerized Systems Validation Lead Europe

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 20000 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:

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 Masters or Bachelors 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 31 6