Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The Quality Assurance (QA) Specialist of the Quality Assurance Group coordinates employees training process in accordance with GGP requirements, prepares and updates quality assurance documents, checks documentation related to GGP processes, participates in the resolution of deviations, non-conformities and complaints.
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.
Requirements for qualification / Education / Experience:
Main qualification, education and Experience requirements for position are:
- 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)
The company offers:
- The environment of a rapidly growing international innovative company;
- Personal and professional career opportunities in the field of high technology;
- The possibility to go to/from work by free bus, 70% compensated lunch in the company canteen, we serve coffee/tea;
- An incentive package of additional benefits (annual bonus for results, accident insurance, health insurance).
- Salary 1980– 2970 Eur /month before tax.
Compensation
The salary range estimated for this position based in Lithuania is €23 800,00–€35 650,00.