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 a Quality Control Analyst.

Responsibilities:

• Ensure that lab cleanliness and safety standards are maintained. Develop and qualify new testing methods.
• Train other analysts to perform laboratory procedures and assays. Participate in internal and external audits as required.
• Identify and troubleshoot equipment problems.
• Evaluate new technologies and methods to make recommendations regarding their use.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors. Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Write or revise standard quality control operating procedures.
• Supply quality control data necessary for regulatory submissions. Receive and inspect raw materials.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Prepare or review required method transfer documentation including technical transfer protocols or reports. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines. Participate in out-of-specification and failure investigations and recommend corrective actions.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Identify quality problems and recommend solutions.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Calibrate, validate, or maintain laboratory equipment.
• Compile laboratory test data and perform appropriate analyses.
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

Requirements:

• Bachelor’s degree (Chemistry)
• Postgraduate degree is desirable
• 1+ year of related pharmaceutical laboratory experience in a cGMP environment
• Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting
• Fluency in English language written and oral.

Benefits

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