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As Report Writer you will be part of the Process Solutions Services team that designs and delivers Viral Clearance validation studies for biopharmaceutical companies across the APAC region. The Report Writer is responsible for the preparation of Final Reports and Certificates of Analysis using data obtained from GLP/GMP assays performed across all Bioreliance Biotesting Lab in Singapore. In collaboration with the laboratory personnel, the Report Writer summarizes the life cycle, technical processes and assay results of a sample in a Final Report. The Report Writer will work closely with the Study Directors to prepare the study file and generate the final report on time. The Report Writer will review batch records, process data and perform trend analysis data to ensure consistent assay performance and scientific integrity of the study.
The post holder needs to have an understanding of technical/ scientific observations and ensure all documentation generated fulfils quality and regulatory standards and practices (GLP or GMP) as well as client specific requirements when reporting assays. The post holder will be proficient in generating reports in English and is able to translate to Mandarin report when required for clients for regulatory filing with respective local regulatory government.
Brief role description:
- Summarizes technical data into a high-quality report or certificate of analysis as required, in a timely manner
- Is familiar with study-specific protocols, technical specifications, applicable SOPs and regulatory requirements
- Prepares study reports and any applicable study associated Final Report/Certificate of Analysis amendments according to specific client requests to achieve on time delivery. Address comments on these study reports following Study Director review and Quality Assurance audit
- Generate, control and tracking of revisions to all appropriate Report/Certificate templates
- Translates reports written in English to Mandarin when required
- Progresses CAPA and change controls associated with any aspect of the technical writer function, ensuring records are closed in accordance with the assigned timelines
- Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace
- Review Right First Time (RFT) metrics with the appropriate personnel in order to drive down error rates.
- Input dates into Information management systems and prepare study files for archiving
- Reviews laboratory records and performs statistical analysis to calculate virus titers log reduction factions
- Provides hands-on support to the lab team by performing virus titration assays, virus infectivity reads and virus titre calculations when required
- Performs trend analysis to ensure the assay remains in the qualified state of control
- Prepares system reports in support of huddles and metrics tracking
Who You Are:
- Master/Bachelor in Biology/Biological Sciences/Life Sciences or higher degree in relevant scientific subject
- Minimum 1-2 years of experience in a scientific laboratory role
- Previous experience in scientific writing
- Previous experience working in a regulated environment (GLP/GMP) would be advantageous
- Adheres to SOPs and protocols, and ensures compliance to site policies and regulations
- Proficient in written Chinese with demonstrated capability to translate scientific document from English to Mandarin for clients for filing with respective local regulatory government
- Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
- Ability to complete documentation (both handwritten and electronic) clearly and accurately
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com