Devya B. Email & Phone Number

Singapore

Singapore, Singapore

Singapore

• Reviewed executed logbooks to ensure Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) were followed, and when necessary, raised deviations
• Detected non-compliance with cGMP and GDP requirements and provided guidance on GDP corrections
• Supported routine Quality Assurance activities in accordance to approved Standard Order of Procedures (SOP) and provide basic compliance support by collaborating with the team and other departments
• Provided assistance to the team during audit by gathering documents, conducting preliminary review into the documentation required, and reconciling records
• Acquired a thorough understanding of process workflow and identified operational elements requiring quality oversight
• Applied problem solving skills by acquiring data and performing trend analysis to find recurring errors found during documentation review

Singapore

• Collaborated with Regional leaders, Local leaders and team members to implement lean tools and methods in RSTO such as LPS (Lean Production System) and SASTRiP (See & Solve the Right Problem)
• Supported various site prioritized Continuous Improvement (Kaizens) Projects, planned agendas for the working sessions after performing Gemba walks in cleanroom adhering to GMP standards, managed complex datasets, and.
• Co-Facilitated Contamination Taskforce Project to holistically evaluate the mammalian cell production process, identify key areas for improvements and recognize potential actions that would reduce the likelihood of.
• Lead the team in revamping an initiative known as “Innovation University” by developing a well-structured framework and a detailed process flow using Agile principles and A3 problem solving tool that aimed to promote.
• Organised a Hackathon to launch and raise awareness about Innovation University with participants from various departments to produce a tangible idea involving robotics and automation to improve current processes

Singapore

• Ensured regular update of product registration trackers and regulatory affairs database of medical device products in ASEAN
• Adhered to good documentation practices to ensure all processes are recorded legibly and readily accessible when required
• Collaborated with regional counterparts to gather relevant documents required in the preparation of a CSDT (Common Submission Dossier Template) for Malaysia, Cambodia and Myanmar
• Ensured that post market records are in proper order for Good Distribution Practice for Medical Devices (GDPMD) audit
• Assisted in tracking and timely submission of Field Safety Corrective Action (FSCA) and Adverse Event (AE) reports to Health Science Authority (HSA) to ensure the products met the regulatory compliance standards
• Re-registered approximately 900 GE medical device products to cater to Malaysia’s new Medical Device Act and ISO 13485

Bachelor Of Pharmaceutical Engineering

Biomedical Engineering, Biomedical/Medical Engineering