Įminė Thermo Fisher Scientific Baltics, UAB Position purpose: This role is responsible for leading process validation activities in Vilnius Operations. Together with manufacturing and quality assurance teams this specialist will create process validation plans, forms, and reports, will coordinate activities during validations and is responsible for process optimization.
 
Key Responsibilities:

Leading process validation activities:
Ensures all vital quality standards are met and processes are validated.
Initiates and actively leads meetings for process validation strategy development.
Coordinates different activities during process validation.
Timely fulfils planned activities and provides plans, forms and rapports.
Suggests manufacturing process improvement to better meet ISO standard requirements
Ensures an effective manufacturing teams support during process validation.
Actively indicates risks and translates them to the validation team.
Validation documentation management:
Prepares and updates procedures associated with validation activities in Vilnius site
Creates, updates, and approves validation plans, forms, and rapports
Generates ideas how to standardize and improve documents creation process
Non-conformities and deviations management during process validation
Analyses batch records, testing and development data to identify variations
Generates ideas how to find the root cause
Actively uses PPI tools and methods:
Participates and leads JDI and Kaizens
Goes to GEMBA walks and implements 5 S
Is an active team member:
Generates ideas and executes process improvement
Mentors and coaches the team members
Provide technical expertise and knowledge on validation to manufacturing group and beyond.