Biotechnology postgraduate with 6+ years of experience in Clinical Documentation, SOP Lifecycle Management, and Training Coordination within regulated GxP/GMP environments. Skilled in managing end-to-end document lifecycles, ensuring compliance, audit readiness, and cross-functional alignment.
Proficient in Veeva Vault, SAP GUI, SuccessFactors, Documentum, Power BI, Spotfire, and Excel automation (Macros, Power Query) to streamline processes and deliver data-driven insights. Recognized with multiple awards for accuracy, efficiency, and commitment to quality, particularly in supporting vaccine R&D documentation processes.
Currently seeking to leverage expertise in document control, compliance, and data-driven reporting to contribute to a leading pharmaceutical or biotechnology organization.
➤ Managed the full lifecycle of SOPs and GxP-controlled documents, ensuring traceability and audit readiness using Veeva Vault and SAP GUI.
➤ Coordinated training schedules and compliance tracking, resulting in timely completion of assignments.
➤ Collaborated with global QA, RA, Clinical, and Business Development teams to meet regulatory documentation standards.
➤ Proficient in EDMS tools including Veeva Vault, SAP Logon, Documentum, and SuccessFactors.
➤ Maintained Power BI and Spotfire dashboards, automating Excel reports to enhance accuracy and deliver insights.
➤ Utilized advanced Excel functions (Macros, Power Query) to improve reporting efficiency.
➤ Leveraged basic SAS for generating compliance metrics and reporting analytics.
➤ Received multiple “Star of the Month” awards for consistent high-quality performance and dedication.
Document Control (GxP/GMP): Extensive experience managing controlled documents and SOPs through their full lifecycle in compliance with global regulations
EDMS Expertise: Proficient in Veeva Vault, SAP, and Documentum; supported end-to-end SOP/document migration to Veeva QualityDocs
Training & Compliance: Coordinated training, maintained learner compliance, and ensured audit readiness
Documentation & Review: Skilled in managing technical/clinical documents, metadata classification, and compliance reviews for accuracy and regulatory alignment
Technical Skills: Advanced MS Office; working knowledge of Power BI and SAS
Collaboration & Leadership: Cross-functional teamwork with QA, RA, Clinical, and Business units; trained colleagues and supported process improvements
I hereby declare that the information provided is accurate and complete to the best of my knowledge.