Cloud Validation Professional

3 days ago

Singapore beBeeQuality Full time $80,000 - $120,000
Job Title:
Quality Assurance Specialist

At our company, we are seeking a highly skilled and motivated Quality Assurance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the quality of our products and services.

Job Responsibilities:
Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow. Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems. Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions. Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking. Develop and configure TrackWise workflows and ensure proper documentation. Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance. Document test results, deviations, and corrective actions, and ensure alignment with validation protocols. Contribute to the promotion of our services on top of assistance provided to clients.

Required Skills and Qualifications:
Bachelor's degree in Computer Science, Life Science, or a related field. 1-2 years of experience in validation of computer systems in the pharmaceutical industry. Proficiency in Kneat, TrackWise, CAPA, and change control processes. Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5). Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations. Strong documentation and technical writing skills. Excellent communication skills, both written and verbal, in English.

Benefits:
We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development. Our team is dedicated to providing excellent support and resources to help you succeed in your role.

Others:
Candidate must be highly motivated, able to work independently as well as in a team, and possess good organizational and oral and written communication skills. Platform and Cloud Hosting Team responsibilities include deploying, supporting, and maintaining global Private Cloud infrastructure, advising internal partners on how to leverage the Cloud, and guiding and assisting our application team to adopt cloud-native technologies.

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