KLEVA Pharmaceuticals S.A. is a privately owned pharmaceutical and fully integrated company that has been in operation in Greece for over 50 years. Kleva develops and manufactures generic products and focuses on Pharmaceuticals (Rx & OTC).

Our two manufacturing facilities in the North of Athens, Greece, are equipped with high technology machinery and have the manufacturing potential for a wide range of pharmaceutical forms.

Our mission is to offer a flexible, fully scalable, qualitative, and cost-effective product development in a wide range of dosage forms. We register and export our products to a number of regulated and non-regulated markets around the world.

To realize our ambitious goals, KLEVA needs people who are innovators, believe in the values of respect and cooperation and are ready to commit to a company that wants to penetrate new markets, leverage international business development opportunities, and enter contract manufacturing deals.

How you will support our mission

                         We are looking for Quality Assurance Officer

DUTIES AND RESPONSIBILITIES:

       The QA Officer will contribute to the development, maintenance, and continuous improvement of the Quality Management System and ensure compliance with applicable GMP standards and regulatory requirement and in particular shall:

• Support the development, implementation and improvement of Quality Management System.
• Draft, revise, and review Quality procedures, SOPs, and other relevant documentation.
• Ensure compliance with approved product dossier and regulatory requirements.
• Participate in investigations of Out of Specification (OOS) and Out of Trend (OOT) results, deviations, and customer complaints.
• Monitor and track CAPA (Corrective and Preventive Action) implementation and effectiveness.
• Contribute to risk assessments related to nitrosamine impurities, elemental impurities, and other product or process-related risks.
• Participate in media fill studies and other validation or qualification activities
• Participate in internal/external audits and support drafting of audit reports.
• Collection, compilation and assessment of statistical quality data and metrics to identify trends and areas for improvement.
• Contribute to GMP training programs and maintain accurate training records.
• Support the preparation of Annual Product Quality Reviews (APQRs) and other quality reports.
• Assist in the preparation and monitoring of Change Control documents.
• Issue and review of Process Validation Protocols/Reports.
• Communicate effectively with internal departments as well as customers.

PROFILE / SKILLS:            

Academic Background

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering or other related field.

Languages:

• Fluency in English both written and oral

Special Knowledge

• Excellent computer literacy (MS Office)

Qualifications 

• Previous professional experience of at least 1-2 years in Quality Assurance or a related field in the pharmaceutical or biotechnology industry is preferred, but not mandatory
• Knowledge of GMP regulations, ICH guidelines, and industry quality standards is an advantage.
• Strong attention to detail, analytical thinking, organizational skills and team working skills.

 Benefits

• Work in a friendly and challenging environment
• Competitive salary
• Private insurance
• Personal development opportunities