Data Integrity Specialist

Hyper Recruitment Solutions; Munster; In loco; EUR 50.000 - 66.000; Tempo pieno

Descrizione del lavoro

Hyper Recruitment Solutions Ltd is seeking a Data Integrity Specialist for a pharmaceutical site in County Waterford, Ireland. You will strengthen laboratory data integrity, optimise Thermo SampleManager LIMS analyses, and automate interfaces with QC equipment, ensuring compliance with regulatory requirements.

You will review data, drive improvements, and contribute to the data integrity maturity across the lab and site, including training and audit readiness.

Competenze

• Relevant scientific or technical knowledge supporting pharmaceutical data integrity activities.
• Understanding of regulatory expectations and good documentation practices.
• Ability to translate data integrity requirements into practical controls.

Mansioni

• Retrospectively review and update LIMS analyses for microbiology and chemistry labs; optimise automated calculations and develop reports/dashboards.
• Configure Thermo SampleManager and automate interfaces between QC equipment and LIMS to improve data capture and reduce manual intervention.
• Embed data integrity requirements across site activities, conduct routine quality checks and oversee computerised system validation.
• Identify training needs, develop content and deliver training on data integrity principles and practices; maintain inspection readiness and participate in audits.

Conoscenze

Data integrity

Regulatory compliance

Quality systems

Laboratory data analysis

Formazione

Bachelor's degree in Chemistry or Microbiology or related

Strumenti

Thermo SampleManager LIMS

Descrizione del lavoro

We are currently looking for a Data Integrity Specialist to join our client, a pharmaceutical company based in County Waterford. As the Data Integrity Specialist you will be responsible for strengthening laboratory data integrity, with a particular focus on improving existing Thermo SampleManager laboratory information management system (LIMS) analyses and automating interfaces with quality control equipment.

This opportunity combines LIMS configuration with site-wide data integrity oversight. You will help microbiology and chemistry laboratories make better use of automated calculations, reports and dashboards, while ensuring regulatory and global quality requirements translate into practical controls across site functions.

This is a 12 month contract with the potential to extend.

KEY DUTIES AND RESPONSIBILITIES:

• As the Data Integrity Specialist, you will retrospectively review and update existing LIMS analyses for microbiology and chemistry laboratories, optimising automated calculations and developing reports and dashboards. Working closely with LIMS suppliers and laboratory stakeholders, you will configure Thermo SampleManager and automate interfaces between quality control equipment and LIMS to improve data capture and reduce manual intervention.
• As the Data Integrity Specialist, you will embed data integrity requirements across site activities, ensuring compliance with regulatory expectations, global quality requirements and company policies. You will conduct routine data quality checks and validations, assess risks, implement mitigation measures and oversee computerised system validation, including appropriate controls for recording, storing and retrieving data.
• As the Data Integrity Specialist, you will investigate data integrity incidents, including potential data breaches or falsification, determine corrective and preventive actions and drive remediation arising from internal and external audits. You will maintain inspection readiness, participate in regulatory inspections and audits, and use their outcomes to prioritise site data integrity objectives and continuous improvement activities.
• As the Data Integrity Specialist, you will identify training needs, develop content and deliver training on data integrity principles and practices. You will generate and review management reports and Data Integrity Maturity Model metrics, advise on cross-departmental strategies and maintain visibility of breaches and inspection outcomes. You will also represent the site in the global community of practice, participate in the centre of excellence when requested, and communicate relevant updates locally.

ROLE REQUIREMENTS:

• Relevant scientific, laboratory or technical knowledge supporting pharmaceutical data integrity activities. A degree in a subject such as chemistry, microbiology or a related discipline would be relevant, alongside an understanding of regulatory expectations and sound documentation practices.
• Proven industry experience with Thermo SampleManager LIMS, including hands-on configuration of laboratory analyses and integration with quality control equipment. Experience working with LIMS suppliers and stakeholders is critical, supported by strong data integrity understanding.
• A working knowledge and practical experience with data integrity controls, including risk assessment, data review, computerised system validation and incident investigation. As a Data Integrity Specialist, you will also draw on your ability to explain requirements clearly, support training and translate findings into effective improvements.

Key Words:

Data Integrity Specialist / Thermo SampleManager / LIMS Configuration / Pharmaceutical Quality / Laboratory Automation / QC Equipment Integration / Microbiology / Chemistry / Data Integrity Maturity Model

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.