Quality Assurance Specialist

Job Description

The Quality Assurance (QA) Specialist of the Quality Assurance Group coordinates the training of employees of products manufactured in accordance with GGP requirements, prepares and updates quality assurance documents and checks documentation related to GGP processes, participates in the resolution of deviations and non-conformities (ensures compliance with ISO 13485:2003 and GGP requirements).

The Quality Assurance Specialist is directly related to the activities performed in aseptic production.

The QA Specialist replaces the Sr. QA Specialist on vacation, illness, business trips, etc.

Key responsibilities:

• Prepares, updates and reviews QA documentation in compliance with ISO 13485 and GMP requirements
• Participates in quality assurance activities (investigates unplanned deviations and complaints, major change process supervision)
• Coordinates GMP risk management processes: Ensures the implementation of risk management activities by participating in or advising the risk management team on risk assessment. Monitors risk control activities.
• Coordinate initial and following trainings for employees working under GMP requirements
• Checks and approves batch production, analysis, environment monitoring protocols, forms related to GMP procedures. Prepares documents required for batch release, provides information to the QA Group Manager.
• Ensures the confidentiality of information acquired at work.
• Provides proposals related to the improvement of the functions performed and the activities of the unit.

• University Bachelor's or Master's degree in molecular biology, chemistry, biochemistry, genomics, or similar fields.
• Excellent English and Lithuanian language skills in verbal and written communication.
• Digital literacy in Microsoft Office (MS Excel, Word, Powerpoint).
• Knowledge of ISO 9001, ISO 13485 quality standards. Understanding of GMP requirements.
• Work experience in a production or research department (would be considered as advantage)