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Life Sciences Validation Specialist
2 meses atrás
Position Overview
We are seeking a dedicated professional in the field of Life Sciences to take on the role of Life Sciences Validation Specialist. This position is crucial for ensuring that our computerized systems meet the necessary compliance standards and function effectively within the regulated environment.
Key Responsibilities
- Oversee the complete GxP change control process for the implementation of computerized systems, ensuring alignment with stakeholder requirements.
- Collaborate with IT and business teams to collect and document user requirements, establishing the intended functionality of the systems.
- Work alongside project stakeholders to develop and refine validation documentation, including Installation Qualification (IQ), Validation Plans, Test Plans, and Test Scripts.
- Coordinate validation activities across diverse teams to ensure adherence to project timelines and proper documentation practices.
- Support the resolution and documentation of testing protocols and results.
- Maintain compliance of computerized systems with applicable regulations and internal standards throughout their lifecycle.
- Assist in post-implementation activities, including user onboarding documentation and quarterly system access reviews.
- Ensure comprehensive documentation for computerized system validation is maintained.
Qualifications
- A Bachelor's or Master's degree in Computer Science, Information Systems, Engineering, or a related discipline.
- Fluency in both Portuguese and English, with strong written and verbal communication skills.
- A minimum of 3 years of experience in computerized system validation, ideally within the pharmaceutical or biotechnology sectors.
Essential Skills
- Demonstrated experience in validating SAP systems.
- Thorough understanding of GxP regulations and industry best practices.
- Strong analytical and problem-solving capabilities, coupled with effective project management skills.
- Familiarity with validation tools and software testing methodologies.
- Ability to work collaboratively with cross-functional teams and stakeholders.
Soft Skills
- Excellent communication and interpersonal skills.
- Strong leadership and decision-making abilities.
- Capacity to understand business needs and facilitate a holistic perspective.
- Motivated to continuously enhance knowledge in the life sciences field.
- Ability to manage multiple priorities in a dynamic environment.
- Global coordination skills to work effectively with teams across various levels.
- Awareness of organizational dynamics and the interrelationship of departments.
Benefits
- Flat organizational structure with early responsibility.
- People-centric culture promoting diversity and inclusion.
- Engagement in global projects within a multinational context.
- Flexible working hours and remote work options.
- Opportunities for professional development, training, and coaching.
- Competitive salary package with performance-based bonuses.
If you possess the required qualifications and experience, we encourage you to consider this opportunity to contribute to a global operation in the life sciences sector.
