Experience

LifeHealthcare

• Australia
• Medical Equipment Manufacturing
• 400 - 500 Employee

• Regulatory Affairs Associate

  • Jun 2020 - Present



Anspec Pty Ltd.

• Sydney, Australia

• Senior Quality and Regulatory Associate

  • Jul 2019 - Jun 2020

  • Obtained and maintained critical licenses from NSW Health and Office of Drug Control for fundamental functioning of the business according to Good Wholesaling Practice (GWP) and TGA standards for Schedule 2,3,4 & 8 medicines. • Rendered regulatory consultation services for local/ international customers, clients and internal staff • Created an effective filing system for tracking and maintaining product registrations, licenses, deliveries, permits • Timely review of Quality Documents for ISO 9001:2015 audit, established tracking system for registering Recalls, Safety Data Exchange and Non-Conformances. • Strengthened stakeholder relationship using persuasive and prompt communication strategy • Managed import requirements for Medicinal Cannabis, TGO 93 conformity assessment and final batch release • Established Technical Agreements for Clients, created a QMS documentation system for a business wing in PNG • Due diligence- regular checks for identifying recalls and monitoring adverse events • Fulfilled 3PL and 4PL client requirements from quality and regulatory perspective Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• LOC Quality Executive

  • Jun 2018 - Jul 2019

  • Managed an effective Product Quality Complaints process, collaborated with relevant stakeholders to improve product and process issues • Led and completed a massive project of establishing a robust filing system for batch records • Met customer expectations by timely and detailed review of batch records and authorising its release for sale • Maintained a consistently compliant deviation status and extended cross functional support to meet quality objectives • Braced business to be audit ready and fulfilled diverse responsibilities leading to it • Assisted in management of quality agreements and ensured their effectiveness, sustainable KPI • Presented reports before Quality Council, identified trends and potential risks, timely escalations • Participated in regional knowledge/ process enhancement initiatives Show less



BTG plc

• United States
• Medical Device
• 200 - 300 Employee

• QA Officer

  • Dec 2016 - Jun 2018

  • Enhanced the efficiency of QMS by playing a vital role in strategic planning, collaborating and seamless execution of a transformational data migration project• Partnered across different business verticals in establishing a paperless Document Control system and facilitated its successful implementation by building capability• Optimised team’s performance and reduced cross-functional barriers by promoting Right First-Time culture through effective training and communication models• Issued timeous and error free Batch Manufacturing Records• Supported APQR completion and Change Control Actions Completion on time• Integrally involved in Risk Management discussions and escalation of potential quality risks• Identified Quality Events, initiated its investigation, CAPA and effectiveness checks• Prepared site and participated in TGA Inspection for GMP standards• Organised and performed 3 internal and 2 external audits encompassing report writing till audit closure. Trained in Internal Auditing and Data Integrity courses• Improved records retention process aligned with ALCOA principles for safeguarding quality document’s integrity, traceability and appropriate destruction• Engaged in continuous learning and contributed to process improvement ideas of quality management system within QA and cross functional teams Show less

• Document Controller

  • Apr 2016 - Dec 2016



Quintiles Research (India) PrivateLimited

• India
• Biotechnology Research

• Senior Drug Safety Operations Specialist

  • Apr 2010 - Dec 2015

  • Performed end-to-end processing of Individual Case Safety Reports for clients across different geographical locations • Transformed adverse event experiences into superior quality reports aligned with global regulatory standards • Project lead for newly transitioned product • Delivered classroom and on-the job training for new hires and mentored cross functional teams in various aspects of Pharmacovigilance activities • Collaborated with internal and external stakeholders to set up new projects and solved operational problems • Made recommendations for process improvement for streamlining safety reporting • Random dip stick sampling to ensure accuracy and consistency of reports impacting the life cycle of a product and patient safety • Intrinsically involved in managing deviations, proposing CAPAs and driving their effectiveness • Established way of working to improve quality and consistency- outlined a process to be followed when a case is reported by a “non-quality review certified” associate • Participated in internal audits and regulatory inspections besides driving team’s preparedness Show less



Syngene International Limited

• India
• Research Services
• 700 & Above Employee

• Scientist

  • Jun 2008 - Apr 2010

  • Independently planned and executed Pharmacological studies in rodents according to the protocol and best practices to deliver high quality results • Sample analysis, report generation, drew scientific conclusions based on experimental observations and record keeping • Participated in exploratory projects aiming to establish more efficient sampling techniques • Supported in collecting data that addressed PK/PD/ADME related issues for the advancement of high-quality drug candidates from discovery into development • Mentored and trained a junior scientist in surgical skills, report generation and data analysis Show less