Stability Analyst (Pharma)

LMW  is seeking for a  Stability Analyst  on behalf of a Greek pharmaceutical company located in the North-Western region of Athens. The company manufactures both sterile and non-sterile products and is focused on exports worldwide.

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
• 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
• 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

The Stability Analyst will be part of the highly qualified team in a fast-paced environment that offers competitive remuneration and opportunities to grow.