Senior QA Scientist

We are looking for:

A Senior QA 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 Senior QA Scientist you will be responsible for:

• 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.
• 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).

What you will bring:

• 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.
• 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.
• Critical Thinking
• Team-oriented, adaptable, and proactive.
• Able to work under fast paced situations
• Knowledge of audit procedures and basic statistical tools is considered a plus..
• Good knowledge of Microsoft office tools
• Good knowledge of Greek & English languages