Validation and Qualification Scientist
Job Description
We are looking for:
We are looking for a Validation and Qualification Scientist to support and execute qualification and validation activities for facilities, utilities, equipment, computerised systems, processes, and cleaning programs in accordance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company procedures.
As a Validation and Qualification Scientist, you will:
•Participate in reviewing, approving, setting the requirements and verifying the engineering department and 3rd party vendors for the qualification activities of production equipment, HVAC systems, cleanrooms, utilities (WFI, purified water, compressed air, etc.), and analytical instruments.
•Participate in reviewing, approving, setting the requirements and verifying process validation & cleaning validation activities as per validation master plans and regulatory requirements.
•Support review and approval of validation protocols (IQ, OQ, PQ), reports, risk assessments, and related documentation.
•Verify timely execution of periodic requalification and revalidation as per schedule.
•Support relevant stakeholders with the coordination, planning and execution of validation-related activities
•Ensure compliance with cGMP, FDA, EU, and other global regulatory guidelines relevant to qualification and validation.
•Supporting regulatory inspections, internal audits, and customer audits.
•Support review and approval of Validation Master Plans (VMP), SOPs, and other QA documentation related to validation.
•Investigate & report deviations, change controls, and CAPAs related to validation activities.
•Support technology transfers and new product introductions from a qualification perspective.
•Work closely with cross-functional teams (Production, QC, Engineering)
What you will bring:
•Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, Chemistry, Biochemistry, Biology or any other related field
•2 years of experience in pharmaceutical QA (qualification/validation) in GMP manufacturing
•Knowledge of GMP, EMA, FDA, WHO, ICH regulations & ISPE guidelines
•Experience in Calibration and Verification of equipment acc. ISO17025
•Good knowledge of the ISO14644 Suite
•Good knowledge of qualification and validation lifecycle and risk-based approaches
•Excellent documentation, review, and audit preparedness skills.
•Analytical thinking and problem-solving skills.
•Strong communication, organisation, and analytical skills.
•Proficient in Microsoft Office (Word, Excel, Outlook).
•Greek & English language: fluent (written and spoken)
If you are interested, you can apply via our website: https://careers.remedica.eu/job/Validation-and-Qualification-Scientist/1120-en_GB/
How to Apply
Interested candidates are kindly requested to send their CV to the HR Manager at talent@remedica.com.cy.
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About Company
Remedica Ltd
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.
Join Our Team !
At Remedica, we take pride on our diverse workforce, a global collective of talents representing a multitude of both academic and professional backgrounds. In the tapestry of our organization, our employees are the vibrant threads that bring it to life. Our success is driven by our talented employees that are committed to excellence. For this reason, we are looking to recruit the most talented people from across the world, who bring a diverse range of experience and capabilities to our existing team of experts.
Transparent Communication
We value transparency and effective communication, which is why we regularly host townhall meetings, round tables and open discussions where we share important updates, celebrate our collective successes and provide a platform for open dialogue between leadership and employees.
Cultivating Team Spirit
At Remedica we believe that strong teams drive exceptional results. Our team building events, including parties and social gatherings, offer our people the opportunity to connect on a personal level, strengthen their bonds and build lasting relationships.
Community Engagement
We are also committed to building strong, supporting relationships within our communities. We encourage our people to participate in volunteering opportunities and community service projects, and through several sponsorships and collaborations, we work to enhance public health, promote educational opportunities and support local causes.
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.