
Validation Specialist
2 weeks ago
We are seeking a Validation Specialist to join our team in Cork, Ireland.
The successful candidate will be responsible for the design and execution of validation projects and strategies to support the implementation of validation master plans and qualification programmes.
- Main Responsibilities:
- Validate manufacturing and associated processes for new facilities.
- Execute process, systems, and equipment validations according to validation master plans, company policies, and project schedules.
- Prepare, execute, and complete validation protocols and reports ensuring compliance with relevant quality standards and regulatory requirements.
- Participate in cross-functional teams to establish validation strategies and objectives.
- Maintain ongoing understanding and knowledge of validation requirements and provide updates to stakeholders.
- Monitor validation project progress to ensure adherence to schedule and provide regular stakeholder updates.
- Ensure thorough investigation of quality and validation issues using root cause analysis methodology.
- Lead risk mitigation initiatives such as FMEA and risk assessments.
- Adhere to all quality procedures and EHS guidelines.
To be successful in this role, you will need:
- Bachelor's degree in an appropriate science or quality assurance discipline.
- Strong understanding of cGMP, ISO, and other relevant regulatory standards.
- Thorough, practical, and persistent self-starter with strong motivation.
- Good verbal and presentation skills.
- Strong written communication skills with proven technical report writing skills.
- Demonstrated success working in a team environment.
- Effective time management skills to meet project schedules.
- Good problem-solving skills.
We offer a dynamic work environment, opportunities for professional growth, and a competitive compensation package. If you are a motivated individual with a passion for validation, we encourage you to apply for this exciting opportunity.
This role involves travel abroad. We are an equal opportunities employer and welcome applications from diverse candidates.
About UsWe are a leading global healthcare company that is committed to improving human lives through innovative science and technology. Our company values diversity, inclusion, and employee empowerment. We strive to create a workplace that is inclusive, supportive, and challenging for our employees.
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