Pharmaceutical Quality Assurance Specialist

KLEVA Pharmaceuticals S.A. is a privately owned pharmaceutical and fully integrated company that has been in operation in Greece for over 50 years.

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.

We are looking for a Quality Control Analyst who will play a key role in ensuring the quality of our products.

The main responsibilities of this position include:

• Ensuring lab cleanliness and safety standards are maintained
• Developing and qualifying new testing methods
• Training other analysts to perform laboratory procedures and assays
• Identifying and troubleshooting equipment problems
• Evaluating new technologies and methods to make recommendations regarding their use
• Serving as a technical liaison between quality control and other departments, vendors, or contractors
• Writing technical reports or documentation such as deviation reports, testing protocols, and trend analyses
• Supplying quality control data necessary for regulatory submissions
• Reviewing data from contract laboratories to ensure accuracy and regulatory compliance
• Preparing or reviewing required method transfer documentation including technical transfer protocols or reports
• Performing validations or transfers of analytical methods in accordance with applicable policies or guidelines
• Participating in out-of-specification and failure investigations and recommending corrective actions
• Interpreting test results, comparing them to established specifications and control limits, and making recommendations on appropriateness of data for release
• Identifying quality problems and recommending solutions
• Evaluating analytical methods and procedures to determine how they might be improved
• Completing documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms
• Calibrating, validating, or maintaining laboratory equipment
• Compiling laboratory test data and performing appropriate analyses
• Conducting routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples

The ideal candidate should have:

• 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

We offer a competitive salary, private insurance, and personal development opportunities.