QA Scientist

QA Scientist

Remedica

Limassol, Cyprus

We are looking for:

A Quality Assurance Scientist to maintain & improve Remedica’s Quality Management System and Operational readiness in order to ensure compliance with GMP regulations concerning quality, safety and efficacy.

As a QA Scientist you will:

• Prepare/issue/review and control of GMP documentation including SOPs, controlled documents, protocols and reports, logbooks. Support document issuance, archiving, and version control.
• Record, track, and perform investigation of deviations and out of specification results.
• Ensure timely initiation and closure of deviation reports.
• Initiate, assess, and track of Change Control records, Ensure risk-based evaluation of changes and appropriate documentation.
• Draft and follow up on Corrective & Preventive actions derived from deviations, audits, complaints, etc. Monitor implementation and verify effectiveness in collaboration with QA team.
• Participate in Interal & External Audits.
• Support complaint intake, initial assessment, and coordination of investigations. Participate in the investigation and completion of complaint reports
• Assist in mock recall and documentation of recall procedures.
• Collect and compile data for annual product quality review.
• Assist in evaluation of trends, deviations, OOS, returns, complaints, and CAPAs.
• Participate in Quality Risk Management activities such as risk assessments and mitigation planning.
• Review of qualification/validation protocols and reports (equipment, process, cleaning, transport).
• Assist in review of manufacturing and packaging batch records. Ensure compliance with BMR/BPR SOPs and GMP requirements. Monitor manufacturing and packaging activities for GMP compliance.
• Executing onboarding training for new staff and ongoing compliance training activities.
• Maintain training records and ensure training documentation is accurate and up to date.
• Maintain a log of Quality Agreements with third-party service providers and partners Assist in the drafting, reviewing, and revision of quality agreements in collaboration with relevant departments.
• Assist with preparation of quality reports, metrics, and management review data.
• Contribute to the continuous improvement of QMS processes and support inspection readiness.

What you will bring:

• Bachelor’s Degree in Pharmacy, Chemistry, Biochemistry, Biology, Chemical Engineering or any other related field.
• 2-3 years’ experience in pharmaceutical QA/QC or GMP manufacturing.
• Understanding of GMP (EU, WHO), GDP, and basic pharmaceutical regulations.
• High attention to detail and good documentation practices (GDP).
• Strong communication, organization, and analytical skills.
• Team-oriented, adaptable, and proactive.
• Able to work under fast paced situations.
• Proficient in English language.
• Good knowledge of Microsoft office tools.