Lead and execute validation efforts for computerized systems to ensure compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
Develop, review, and approve validation documentation such as Validation Plans, Risk Assessments, Requirement Specifications, Test Protocols, and Validation Reports.
Conduct periodic reviews of validated systems to ensure ongoing compliance and revalidate as necessary.
Collaborate with cross-functional teams, including IT, QA, and Operations, to ensure aligned validation strategies and seamless project execution.
Investigate and address discrepancies or anomalies during validation activities.
Stay updated with emerging regulations and best practices in computerized system validation.
Conduct training for relevant stakeholders on CSV principles and best practices.
Support internal and external audits by providing expertise and documentation related to computerized system validations.
Your experience and qualifications
Technical or scientific education (preferably in the field of Engineering, IT, Life Science or similar). You can be last year student.
Excellent computer skills (MS Office and general windows applications)
Able to work independently, systematize and summarize information in written and verbal format
Strong analytical, problem-solving, and organizational skills.
Effective communication skills, both written and verbal.
Familiarity with various software development lifecycles, engineering solutions, equipment, processes.
Good English and Lithuanian language
Advantage: Initial experience in computer system validation in the pharmaceutical sector, GMP guidelines, and knowledge of GAMP5
Enjoy a more rewarding choice
Salary between 1800 - 2600 Euro gross monthly.
Benefits package: health and accident insurance, additional health and vacation days (for worked years)
Highly professional team and organizational culture with strong values
Personal and professional development within the company
Work model supporting work life balance
Employee rewards and recognition programs, events and social activities
Pre-employment verification
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.