Job ID :
Lithuania - Vilnius
- Manage transfer projects to provide documented validation of analytical tests, control systems, utilities and manufacturing processes.
- Document quality systems and programs in the areas of management responsibility, training, validation, corrective and preventive actions, process control, customer complaints, documentation control, etc. to ensure compliance with FDA, ISO 9001, ISO 13485, GMP and regulatory requirements.
- Ensure that established procedures are followed and /or revised accordingly to meet the quality standards and requirements of company policies, FDA, ISO 9001, ISO 13485, GMP requirements.
- Provide validation and manufacturing quality support to the new product introduction manufacturing teams.
- Participates in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
- Develop and establish statistical sampling plans for validation, incoming inspection, etc.
- Identify and support creation of best practices, to provide training and constructive input to team members (e.g. GMP, validation of analytical methods, process validation).
- Solve problems in complicated situations through analytical skills, creativity and judgment.
- Bachelors Degree with at least 4 years of equivalent experience in related industry
- Master Degree preferred.
- Experience in manufacturing, equipment maintenance and supervision; awareness of products characteristics, analytical methods validation, process validation.
- Fluent English (essential).
- Knowledge of established Quality Management Systems, ISO 9001, ISO 13485 regulations, FDA and GMP requirements.
- Excellent computer skills (Microsoft Office).
- Ability to lead, direct and manage cross-functional teams and get results through others.
- Excellent communication skills, including writing, articulating, listening, and questioning skills required.
- Ability to work independently and in team environment
- Attention to detail, accuracy, diligence and responsibility.