Remedica is a globally active EU-based pharmaceutical company, headquartered in Cyprus and present in more than 110 countries. Founded in 1980, the company has evolved into a trusted generics CDMO and dossier development partner for pharmaceutical companies worldwide. Remedica combines development expertise, EU-based manufacturing capabilities, regulatory know-how and a strong quality culture to deliver competitive, high-quality medicines. Its portfolio includes over 300 products across key therapeutic areas, including cardiovascular, oncology, anti-diabetic, anti-infective, central nervous system, alimentary tract, genito-urinary and musculoskeletal treatments.

Over the last few years, Remedica went through a massive transformational program from a locally recognised reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.

Job Purpose:

The Data Integrity Scientist supports the implementation and execution of the organisation’s Data Integrity and Data Governance program across GxP-regulated areas, with a focus on GMP operations.

The role is responsible for performing Data Integrity assessments, supporting remediation of identified gaps, documenting data flows, reviewing procedural controls, assisting with audit trail review processes, supporting training activities, and following up corrective and preventive actions.

The Data Integrity Scientist works closely with Quality, Validation, QC, Manufacturing, Engineering, IT, and system owners to ensure that GxP data are generated, processed, reviewed, retained, and archived in compliance with ALCOA++ principles and applicable regulatory expectations.

This position is based in Limassol. The company offers relocation support for candidates who are considering moving to Cyprus.

Duties and Responsibilities:

• Support execution of the company’s Data Integrity program in accordance with approved policies, procedures, standards, and governance expectations.
• Support Data Integrity gap assessments for GMP systems, processes, records, instruments, spreadsheets, and hybrid data workflows.
• Document and maintain data flow maps covering data creation, processing, review, approval, reporting, transfer, retention, archival, and retrieval.
• Support identification of Data Integrity risks within manual, electronic, and hybrid processes.
• Assist in the preparation of Data Integrity risk assessments, remediation plans, action trackers, and status reports.
• Support remediation of identified Data Integrity gaps, including follow-up of assigned corrective and preventive actions.
• Monitor Data Integrity CAPAs and escalate overdue, ineffective, or high-risk actions to senior team members or Quality management.
• Review SOPs, forms, logbooks, protocols, reports, and other GMP documents to ensure appropriate Data Integrity controls are included.
• Support implementation of audit trail review processes, including preparation of review checklists, procedural guidance, sampling plans, and documented evidence.
• Assist system owners and process owners with defining and documenting audit trail review requirements.
• Provide guidance to relevant stakeholders and participate in assessments of user access management, role permissions, administrator privileges, shared accounts, and segregation of duties.
• Support Data Integrity-related deviation investigations, root cause analysis, CAPA definition, and effectiveness checks.
• Assist with change controls where Data Integrity or data lifecycle controls are impacted.
• Support CSV activities by reviewing documentation for Data Integrity requirements, where required.
• Assist in preparation for internal audits, customer audits, and regulatory inspections involving Data Integrity topics.
• Support collection, organisation, and verification of Data Integrity inspection readiness evidence.
• Provide support for Data Integrity training, including preparing materials, delivering basic awareness sessions, and tracking completion.
• Maintain Data Integrity trackers, metrics, dashboards, and periodic status reports.
• Promote awareness of ALCOA+ principles and good documentation practices in daily GMP operations.

Qualifications and Skills:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, Computer Science, Life Sciences, or a related scientific discipline
• 2+ years of experience in GxP regulated environments (pharmaceutical, biotechnology, medical device) within Quality Assurance, Validation, QC, Manufacturing, Engineering, IT Quality, or Data Integrity.
• Experience in a pharmaceutical, biotechnology, or other GxP-regulated environment.
• Experience in Quality Assurance, Quality Control, Manufacturing, Validation, Engineering, IT Quality, or a related GMP function. 
• Practical experience with GMP documentation, deviations, CAPAs, change controls, SOPs, validation documents, or batch / laboratory records. 
• Good knowledge of Data Integrity principles, ALCOA++, audit trails, manual, hybrid and electronic data and records. 
• Experience in conducting gap assessments, remediation activities, internal audits, or inspection readiness activities is desirable. 
• Experience working with GMP systems such as LIMS, ERP, QMS, SCADA, BMS, EMS, laboratory instruments, or validated spreadsheets is advantageous. 
• Working knowledge of GMP requirements and expectations for Data Integrity and Data Governance. 
• Good understanding of applicable regulatory and industry expectations (EU GMP, FDA, WHO, MHRA, PIC/S, ICH, ISPE) 
• Strong knowledge of regulatory expectations & ALCOA++ principles and practical application across manual, hybrid, and electronic data processes and data lifecycle controls. 
• Ability to translate regulatory expectations into practical, risk-based procedures and controls. 
• Ability to perform structured Data Integrity assessments using approved checklists, templates, and risk tools. 
• Ability to document data flows clearly and accurately. 
• Ability to review procedures and records for Data Integrity gaps and control weaknesses. 
• Ability to support audit trail review activities and identify potential anomalies or review concerns. 
• Good understanding of deviation, CAPA, change control, and document control processes. 
• Ability to maintain trackers, action logs, metrics, and status reports accurately. 
• Good technical writing skills for assessments, reports, procedures, meeting minutes, and remediation documentation.
• Proficient in Microsoft Office (Word, Excel, Outlook).
• Excellent Greek & English languages

Why Join Remedica?
At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.

Equal Opportunity Statement
At Remedica, we are committed to ensuring equal pay for equal work and work of equal value. To support this commitment, roles are evaluated using a structured, gender‑neutral job evaluation framework, which objectively assesses the knowledge, skills, responsibilities, effort, and working conditions associated with each role. This approach helps ensure fair, transparent, and consistent outcomes across the organization.

We welcome applications from all qualified candidates, regardless of sex, race, ethnicity, disability, religion or belief, sexual orientation, gender identity, or age.