No more applications are being accepted for this job
- Plan and coordinate computer software validation projects and activities
- Provide regulatory compliance, guidance, and support on CSV activities
- Create, review, and approve system validation deliverables, such as validation plan
- Participate in projects on setting up quality management system and quality risk management
- Create and modify validation documentation including but not limited to the following:
- Criticality assessments
- CSV protocols (SAT, IQ, OQ) which verify if the system is compliant to regulatory and client requirements
- Reports which summarize the result of the protocol execution
- Support in the review and interpretation of data for accuracy in completed validations
- Contribute to status reporting
- Review executed protocols and generated reports in accordance with GMP and document quality requirements
- Assist in troubleshooting issues identified by test performers during protocol execution
- Bachelor's degree in Pharmaceutical Science, Life Science, Biology, biotechnology chemistry, chemical engineering, engineering, or a related discipline
- Experience in computer system validation for qualifying Electronic Batch Management systems
- Validation experience in reviewing and approving computer system validation lifecycle documentations, e.g., IQ, OQ, PQ protocols and reports
- Hands-on experience in performing equipment validation
- Strong written and verbal communication skills
- 6+ years of experience in Pharma/Life Sciences would be preferred
- Interested in working in a multinational & demanding environment where excellence is the main driver
- Keen sense of communication, strength of conviction, leadership, ability to identify talent and adapt to the local economy
Lead Data Engineer - Singapur, Singapore - Amaris Consulting
Description
Job description About the job
As a CSV Engineer, you will be responsible for preparing and executing test documentation for GMP computerized systems, as well as providing support in the troubleshooting of issues during the test execution. You should have an excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. To succeed in this role, you will be typically responsible for the following:
About you
We are seeking professionals with an entrepreneurial spirit, and ambitious self-starters who embrace challenges, to join our talented team at Amaris.
Oth ers: