Website Duopharma Biotech Berhad
- Assist in organizing, coordinating and conducting QA planned GMP training for all departments to support continuous understanding, application and compliance of cGMP
- Responsible for checking and ensuring company SOPs and quality documents including validation documents, protocols and reports, for standard format, timely reviews, proper distribution/destruction records, traceability and compliance including updating of Site Master File
- Assisting in documentation planning, preparation and review for process related activities
- Supporting in-process Quality Assurance checking and monitoring of product batches during manufacturing and packing
- Assist in checking Batch Manufacturing Records (BMR), including environmental monitoring and quality control reports, for compliance to specifications
- Refer major non-standard and product quality issues to QA Sr Executive and QA Manager for immediate response time
- Review and check that all batch information and all production documentation such as Batch Manufacturing Records, record forms and COAs, are accurate and results are within specifications for batch release approval
- To assist with practical operational changes and improvements within quality system, recommending and acting to improve process, procedures and systems and identifying and supporting actions to resolve quality problems from both internal issues and from outside suppliers
- Check and administrate change control and monitor progress to ensure all the changes are completed as per schedule
- Assisting with the planning and coordination of external, internal and vendor audits to ensure compliance to cGMP, regulatory requirements and QMS standards
- Assist and/or lead in the preparation of product quality review report as per planned schedule and assess for trends
- Coordinates risk assessment projects and assists in the report preparation and compilation to manage risks to product quality
To apply for this job email your details to recruitment@duopharmabiotech.com