Quality Assurance Specialist
1 month ago
Job Summary:
The Validation Technician provides critical support in validation activities across various environments, ensuring equipment, processes, and systems meet regulatory standards.
Key Responsibilities:
- Validation Execution: Validate manufacturing and laboratory equipment according to established standards and schedules.
- Requalification Management: Oversee areas within the department's requalification schedule to maintain validated processes.
- Documentation and Reporting: Author, review, and approve validation protocols and reports to meet established standards.
- Test Execution: Conduct test protocols, collect samples, record data, and analyse results in cleanrooms.
- Workflow Management: Organize, prioritize, and deliver individual work schedules to meet timelines and deadlines.
- Knowledge Sharing and Training: Provide training, advice, and best-practice guidance in validation topics to colleagues.
- Documentation Systems: Maintain familiarity with Validation department systems to ensure audit readiness.
- Compliance and Safety: Adhere to Good Manufacturing Practice (GMP) principles and Health & Safety guidelines.
Minimum Qualifications & Experience:
- Effective problem-solving abilities with a scientific approach.
- Ability to work independently and as part of a team.
- Skilled in documentation, test writing, and using test instruments and computer systems.
- Background in Science, Engineering, or a technical discipline with relevant certifications or experience.
- Familiarity with quality control and pharmaceutical GMP practices.
Preferred Qualifications & Experience:
- Degree in a relevant field is preferred.
- Experience in GMP aseptic manufacturing.
- Validation experience in areas such as equipment, facilities, computer systems, processes, sterilization, sanitization, or temperature management.
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