We are seeking an experienced and hands-on Quality Assurance Officer to join our dynamic team at CURITY PHARMA. The successful candidate will play a crucial role in overseeing the Quality Assurance processes in our manufacturing facility in Larissa, ensuring the highest standards of product quality and compliance with regulatory requirements. He or she will work closely and under the guidance of our Head of Quality Assurance to implement Curity Pharma's QMS.
Key Responsibilities:
- Supervise and ensure the effective implementation of Curity Pharma's Quality Management System (QMS) under the guidance of the Head of QA, adhering to ICH Q10 Pharmaceutical Quality System and relevant health regulations to safeguard patient safety and product quality
- Monitor and ensure compliance with Good Manufacturing Practices (GMP) and Good Agricultural and Collection Practices (GACP) across all organizational levels
- Prepare and communicate updates on changes to standards, legislation, GMP, and GACP to Senior and Key Management personnel
- Track updates in the European Pharmacopeia and inform Senior and Key Management
- Manage the QMS documentation system, ensuring accurate issuance, management, and retention of SOPs, Master Documents, Master Logbooks, and the Quality Manual
- Enforce adherence to Good Documentation Practices
- Implement and oversee systems for Change Control, Deviation Management, CAPA (Corrective and Preventive Actions), Supplier Qualification, and Customer Complaint management, ensuring effective investigation and resolution processes
- Support the planning, preparation, and issuance of annual Product Quality Reviews (PQRs) for all products
- Coordinate the implementation of the Training Management System, including the development of training plans in partnership with department heads
- Oversee the Self-Inspection System (Internal Audits) and the Management Review System alongside the Head of QA
- Manage the Qualification and Validation System for equipment, systems, utilities, computerized processes, analytical methods, and cleaning processes, ensuring the timely issuance of periodic reports as outlined in the Validation Master Plan
- Assist in executing recall-related activities and mock recalls per the Recall System in collaboration with Qualified Persons and the Head of QA
- Implement and monitor the Quality Risk Management System, contributing to risk assessments within the QA Department
- Maintain the Site Master File
- Conduct investigations into Out of Specification (OOS) and Out of Trend (OOT) results within the QMS and report findings appropriately
- Develop and oversee calibration programs for Quality Control and Manufacturing equipment with the QC team
- Collaborate with the Technical Manager to implement the Preventive Maintenance Program for manufacturing equipment
Requirements
Education and Experience:
- Bachelor's degree in Engineering (Chemical, or related fields), Chemistry, Pharmaceutical Science, or a relevant scientific discipline
- Minimum of 3 years of experience in Quality Assurance, preferably within the pharmaceutical or related industries
Technical Skills:
- Strong understanding of GMP, GACP, and QMS principles
- Experience with validation processes, quality risk management, and regulatory compliance
- Proficiency in quality management systems and documentation tools
Soft Skills:
- Excellent organizational and problem-solving abilities
- Strong interpersonal and communication skills to collaborate with cross-functional teams
- Fluency in English and Greek is required
Preferred Qualifications:
- Advanced training or certification in Quality Assurance or Quality Management Systems
- Familiarity with engineering practices in manufacturing environments
- Proven experience in handling audits, inspections, and CAPA processes
