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/
Οι ενδιαφερόμενοι υποψήφιοι παρακαλούνται να στείλουν το βιογραφικό τους στον Διευθυντή Ανθρώπινου Δυναμικού στο talent@remedica.com.cy.
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