GxP System Validation Consultant
6 days ago
We offer a dynamic and challenging work environment where you can apply your skills and experience to drive results. As a GxP System Validation Consultant, you will play a key role in ensuring the quality and integrity of our systems and processes, while also developing your career in a fast-paced and innovative organization. About QAAgility Technologies
QAAgility Technologies is a leading provider of quality assurance solutions, dedicated to helping businesses achieve operational efficiency and meet regulatory requirements.
Key Responsibilities:
- Lead and manage system validation activities for projects to ensure compliance with relevant regulatory standards (e.g., FDA, GMP, ISO, 21 CFR Part 11).
- Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for systems and processes.
- Coordinate with cross-functional teams (e.g., IT, Engineering, Quality Assurance) to ensure validation requirements are met and maintained throughout the system lifecycle.
- Identify, assess, and mitigate risks related to system validation processes.
- Review and approve validation documentation, ensuring that all documentation meets regulatory and internal standards.
- Ensure proper documentation and traceability for all validation activities, including deviations and corrective actions.
Requirements
- Bachelors degree in Life Sciences, Engineering, Information Technology, or a related field.
- Proven experience as a Validation Consultant, or in a validation role within regulated industries (e.g., Pharmaceuticals, Biotech, Medical Devices, IT).
- In-depth knowledge of industry regulations and standards, including GxP (Good Laboratory Practice, Good Manufacturing Practice), 21 CFR Part 11, and ISO 13485.
- Experience in writing and executing validation protocols (IQ, OQ, PQ) and validation reports.
- Strong project management skills, with the ability to lead validation efforts, coordinate resources, and meet deadlines.
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