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.

The purpose of this position is to maintain & improve Remedica’s Quality Management System and Operational readiness in order to ensure compliance with GMP regulations concerning quality, safety and efficacy.

Duties and Responsibilities

• Act as the primary contact for regulatory authorities pre, during and post Health Authority inspection.
• Ensure compliance with global regulatory requirements ( e.g. EMA, ICH guidelines). Participate and monitor any HA interaction that requires compliance oversight.
• Monitor and interpret new and updated regulations and implement necessary changes
• Prepare/issue/review and control of GMP documentation including SOPs, controlled documents, protocols and reports, logbooks. Support document issuance, archiving, and version control.
• Initiate Change Controls related to regulatory requirement, supplier changes etc. Ensure risk-based evaluation of changes and appropriate documentation.
• Evaluate Corrective & Preventive actions derived from deviations, OOS, complaints, etc. Monitor implementation and verify effectiveness controls.
• Plan, co-ordinate, participate and execute Internal, Supplier and External Audits.
• Manage and ensure timely completion of Corrective & Preventive actions derived from Internal & External Audits.
• Perform onboarding of Suppliers and third-party Services and ensure ongoing compliance and evaluation
• Support customer complaint intake and responses. Participate in the investigation and ensure timely completion of complaint reports.
• Notification and investigation of complaints related to suppliers and third party services.
• Perform recall procedures including mock recall and documentation.
• Evaluation and monitor of Quality Metrics and KPIs.
• Participate in Quality Risk Management activities such as risk assessments and mitigation planning.
• Review of qualification/validation protocols and reports (equipment, process, cleaning, CSV, transport).
• Executing onboarding training for new staff and ongoing compliance training activities.
• Maintain a log of Quality Technical Agreements with suppliers, third-party service providers and partners/customers. Draft, review, and revise quality technical agreements in collaboration with relevant departments.
• Assist with preparation of quality reports, metrics, and management review data.
• Evaluate Allergens, Elemental Impurities, and nitrosamines and other undesirable components for raw materials. Assess risk of components in finished products, prepare, document and share risk assessments outcome and reports.
• Contribute to the continuous improvement of QMS processes and support inspection readiness.
• Ensuring that tasks and processes are executed according to established regulations and guidelines such as Standard Operating Procedures (SOPs), Good Documentation Practices (cGDP) and the current Good Manufacturing Practices (cGMP)

Qualifications and skills

• Bachelor’s Degree in Pharmacy, Chemistry, Biochemistry, Biology, Chemical Engineering or any other related field
• 6–10 years experience in pharmaceutical QA (qualification/validation) in GMP manufacturing.
• In-depth knowledge of international pharmaceutical regulations and guidelines, including cGMP, GLP, FDA, EMA, and ICH standards.
• Demonstrates a team‑oriented, adaptable, and proactive approach when working with cross‑functional teams and external stakeholders, including suppliers.
• Shows strong stakeholder management capabilities and the ability to collaborate effectively in fast‑paced environments while maintaining organisation and coordination of activities.
• Ability to communicate effectively with internal teams, suppliers, customers, and regulatory authorities.
• Demonstrates a high level of attention to detail and adherence to Good Documentation Practices (GDP), combined with strong analytical, investigative, and critical thinking abilities.
• Applies structured problem‑solving to address internal and external compliance issues and gaps, supported by a solid understanding of GMP (EU, WHO), GDP, and pharmaceutical regulatory requirements.
• Excellent knowledge English; Knowledge of Greek is considered as an advantage.
• Good knowledge of Microsoft Office tools

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.