Senior System Validation Specialist
1 month ago
Amaris Consulting is a leading provider of consulting services in the pharmaceutical and biotech industries.
Estimated Salary: $120,000 - $180,000 per year
About the Role:We are seeking an experienced Senior System Validation Specialist to join our team. The ideal candidate will have a strong background in system qualification, computerized systems validation, and analytical instrument validation.
- Develop and execute system qualification protocols for QC systems, including computerized systems, analytical instruments, and control systems.
- Ensure compliance with regulatory requirements and industry standards for system qualification.
- Collaborate with cross-functional teams to define system requirements and specifications.
- Perform risk assessments and impact analyses related to system qualification activities.
- Troubleshoot and resolve system qualification issues to ensure reliable and compliant operations.
- Maintain documentation and records related to system qualification processes.
- Participate in validation activities and support validation engineers in related tasks.
- Contribute to continuous improvement initiatives for system qualification processes.
- Bachelor's degree in engineering, computer science, or a related field.
- Experience in system qualification within the pharmaceutical or biotech industry.
- Knowledge of regulatory requirements such as FDA, cGMP, and ICH guidelines related to computerized systems validation.
- Familiarity with validation principles and practices for analytical instruments and control systems.
- Strong understanding of risk assessment methodologies and validation documentation requirements.
- Excellent communication and collaboration skills.
- Ability to work effectively in a cross-functional team environment.
- Detail-oriented with strong analytical and problem-solving abilities.
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
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