Data Integrity

FAMAR
is a European Contract Manufacturing and Development partner, for the Pharmaceutical and Healthcare industry. Building on our 75 years' expertise, we are your reliable partner to deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our 1.850 employees and with a network of 6 production sites and 2 R&D units, we supply a wide range of 1.800 products for more than 80 international markets.

We are currently looking to recruit a professional to fill the position of
Data Integrity & Digital Transformation Specialist,
to be based in one of our locations, in Greece (Alimos, Anthoussa, Avlonas or Thiva), Italy (Milan) or Spain (Madrid)

Data Integrity & Digital Transformation Specialist

The Data Integrity & Digital Transformation Specialist will lead and oversee initiatives that ensure the accuracy, consistency, and reliability of data across our GxP Operations. This role is pivotal in driving our organization's digital transformation and regulatory compliance efforts while maintaining the highest standards of data integrity.

DUTIES AND RESPONSIBILITIES:

The Data Integrity & Digital Transformation Specialist ensures compliance, reliability, and continuous improvement of computerized systems and digital processes in a GxP-regulated environment. Key responsibilities include:

Surveillance of Computerized System Validation (CSV) & Compliance

• Oversee quality review of validation for GxP-relevant systems (lab instruments, manufacturing equipment, data platforms, software).
• Ensure quality compliance adherence to GMP, 21 CFR Part 11, EU Annex 11, GAMP 5, and internal SOPs.
• Conduct risk assessments and define mitigation strategies.
• Review vendor validation packages for regulatory quality compliance.
• Review and approve periodic system reviews to ensure ongoing compliance and data integrity.
• Act as Quality SME on CSV/Data Integrity matters during audits and inspections.
• Oversee external validation service providers.

Data Integrity & Governance

• Develop and monitor data governance policies to ensure data accuracy, traceability, and integrity.
• Oversee data integrity gap assessments and drive remediation/improvement actions.
• Contribute to lifecycle management practices for computerized systems.

Digital Transformation

• Identify and drive digital process improvements to enhance compliance and operational efficiency.
• Support execution of digital transformation strategy with IT, QA, and business units.
• Lead or support implementation of digital tools, ensuring regulatory alignment.
• Promote user adoption through training and hands-on support.

Cross-Functional & Strategic Support

• Collaborate with QA, IT, Manufacturing, Labs, and Regulatory Affairs on CSV and digital initiatives.
• Serve as Quality SME in projects and audits related to validation and data integrity.
• Support internal and supplier audits and other assigned quality projects.

PROFILE, SKILLS AND QUALIFICATIONS:

The ideal candidate is a highly motivated professional with a strong technical background and a collaborative mindset, capable of driving quality and digital transformation in a regulated environment.

• Strong understanding of Regulatory framework on computerized systems validation and data integrity
• Strong organizational, time management, and multitasking skills.
• Excellent analytical thinking and problem-solving capabilities.
• Ability to work independently and within cross-functional teams.
• Excellent communication skills, both written and verbal, with the ability to convey complex concepts clearly.
• Strong interpersonal skills with the ability to build collaborative working relationships.

Languages:

• Fluency in English (advanced oral and written communication skills) is mandatory.
• Knowledge of Italian, Spanish, German, or Greek is considered an advantage.

Academic Background

• Bachelor's and/or Master's degree in Engineering, Chemistry, Computer Science, or a related scientific/technical discipline.

Special Knowledge

• Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Working knowledge of MS Project and Visio is a plus.
• Familiarity with business process mapping and digital process integration.

Qualifications

• Minimum 5 years in the pharmaceutical/biotech sector with hands-on QA / validation of computerized systems, lab instruments, process/packaging equipment, and automation (e.g., PLC/HMI).
• Strong knowledge of GxP regulations and standards: EudraLex Vol. 4 (Annex 11/15), 21 CFR Part 11, GAMP 5, WHO/PIC/S.
• Proven experience across the full validation lifecycle, including change control and deviation management.
• Skilled in project management: planning, prioritization, stakeholder coordination, and risk mitigation.
• Experience with enterprise/local systems (e.g., ERP, LIMS, MES, CDS, QMS).
• Familiarity with aseptic operations is a plus.
• Detail-oriented with strong documentation and reporting skills.
• Able to manage multiple projects under tight timelines.