Hi, I’m
Kavita Sharma
Grantham Farm,NSW
Overview
28
years of professional experience
Work History
Baxter HealthcareOld Toongabbie, NSW
QA and RA Specialist
09.2023 - 09.2024
Job overview
- Company Overview: https://www.baxterhealthcare.com.au/
- 40 Product submissions and approval by TGA & Medsafe
- Declaration of Conformity Certificate preparation, Essential Principle updating, Label review, IFU review, advertising material review as per the Therapeutic Goods Advertising Code 2022
- Collaborated with New Zealand distributors (USL) regarding WAND notifications
- Adverse event reporting promptly (24 hours, 10 days, and 30 days, follow-up every 30 days, and closure within 120 days)—30 reports closed
- Trained ANZ team on the Complaint handling process and AER process and trigger words
- Support Tenders and contract responses within expected timelines
- Product hold, release in JDE, SAP
- Clear communication with respective stakeholders such as Marketing, Supply Chain, Operations, Technical Services, Manufacturers, OEMs, Warehouse and Distribution (CEVA), EBOS Healthcare Group, USL
- Comply with ACMA regulations for Radiocommunication devices
- Maintained ARTG tracker and MDIR tracker
- NCR & CAPA management
- Https://www.baxterhealthcare.com.au/
Owens & Minor Halyard Australia Pty LtdNorth Ryde, NSW
ANZ QARA Lead
04.2019 - 08.2023
Job overview
- Company Overview: https://www.halyardhealth.com.au/
- Submitted sixty applications within four and half years- PPE, Disinfectant, CPP, Gloves, Gowns, Respirators, Masks, Sterilization Wraps, hot/cold pack
- Continued to improve and optimize QMS to ensure it meets both ISO 9001 and corporate quality system (ISO 13485: 2016) requirements
- Product Customer complaint coordinator
- UDID implementation project lead, UDID Barcode Printer verification/validation coordinator
- New Product submissions – Custom Procedure Packs
- Post-market surveillance – Adverse event reporting
- ETQ (eQMS) Super User: Train new employees, conduct Audits, NCR/CAPA, handle Complaints, Change Control, Supplier Management, and Project Management
- Supplier Qualifications - Supplier Quality Agreement (SQA), Non-Disclosure Agreements (NDA), Supplier Audit ISO9001: 2015
- Identified new product risks and implemented plans to mitigate problems
- Prepared & presented QMR, Trending and analysis, Excel VLOOKUP, Pivot Charts, Power BI User
- Collaborated with cross-functional teams to establish quality assurance goals, objectives, and timelines
- Met project scope and delivery targets with adequate planning and scheduling of testing strategies
- Https://www.halyardhealth.com.au/
Zimmer/Biomet Australia and New ZealandBelrose, NSW
Regulatory Affairs Integration Consultant
02.2017 - 03.2019
Job overview
- Company Overview: https://www.zimmerbiomet.com/en
- Specialise in rebranding projects – merger project
- Registered Class 1, IIa, and IIb medical devices (Dental, Spine fixation systems)
- Selected appropriate product conformity assessment pathway for MD registrations
- 20 Declaration of Conformity (DoC) Certificate preparation
- Maintain label accuracy and artwork review
- Assisted with data migration efforts as necessary while implementing new integrations or system upgrades
- Worked closely with Product managers to establish timelines, milestones, and deliverables
- Communicated regularly with stakeholders regarding project progress, risks, issues, or changes impacting deliverables or timelines
- Collaborated with cross-functional teams to ensure seamless integration and data exchange
- Https://www.zimmerbiomet.com/en
BioMérieux Australia Pty LtdNorwest, NSW
Quality Assurance and Regulatory Affairs Manager
08.2014 - 01.2017
Job overview
- Company Overview: https://www.biomerieux.com/
- Assessed the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulations
- Provided regulatory information and guidance for proposed product claims/labeling
- Assessed regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Identified the need for new regulatory procedures, and SOPs and participated in the development and implementation
- Provided regulatory input and technical guidance on global regulatory requirements to product development teams
- Determined requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Maintained current knowledge of existing and emerging regulations, standards, and guidance documents
- Accurately maintained product information databases
- Performed regulatory assessments by the TGA Act 1989 and Therapeutic Goods (Medical Devices) Regulation 2002 for IVD
- Submitted x15 Class 1,2 and 3 IVD applications (100% approval)
- Mentored junior staff members on best practices in regulatory affairs management
- Https://www.biomerieux.com/
Covidien Pty LtdNorth Ryde, NSW
Regulatory Affairs Associate (Medical Device)
04.2011 - 09.2014
Job overview
- Company Overview: https://www.medtronic.com/covidien/en-au.html
- Achieved milestone of 100% registration assigned to me as part of the rebranding project
- Registered several portfolios: Endoscope, laryngoscope, Respiratory & inhalation, Medical supplies, wound care, Neonatal, dialysis catheters, and surgical mesh
- X 200 Class 1, 1s, 1m, IIa, IIb and Class III medical devices registration with TGA and Medsafe
- Post-market Surveillance activities: Adverse event reporting, voluntary product recall, and complaint handling
- Prepared and submitted documentation for new product registrations, renewals, variations, and license transfers
- Managed communication with regulatory agencies to obtain necessary approvals and maintain good working relationships
- Ensure the ARTG and MDOR tracker management
- Reviewed and analysed regulatory documents to ensure compliance with applicable laws and guidelines
- Review Advertising and promotional material
- Collaborate with IT, Marketing, Customer Service, Supply Chain, Product Management, and Global Development teams
- Continuously contributed to QARA KPIs, goals, and objectives
- Maintained QMS as per ISO9001
- Internal audit and external audit (Suppliers)
- Https://www.medtronic.com/covidien/en-au.html
GE Healthcare Pty Ltd.Sydney, NSW
Regulatory Affairs & Quality Assurance Associate
03.2005 - 08.2007
Job overview
- Company Overview: https://www.gehealthcare.com.au/
- Successfully submitted Class 1, IIa, and IIb medical devices such as diagnostic systems, Ultrasound, Anesthesia delivery, diagnostic ECG, Maternal & infant Care, Patient monitoring, Ventilators, Healthcare IT, Refurbished equipment, parts and accessories by the Therapeutic Goods Act 1989, Therapeutic Goods (Medical device) regulations 2002
- Maintained and kept up-to-date manufacturers’ evidence, TGA registrations, WAND notifications, Annual Charges exemption (ACE), and Annual Charges paid promptly
- Submitted EOL notification to TGA
- Post-market surveillance: MDIR within strict timelines (48 hours, 10 days, 30 days, closure within 120 days)
- Maintained MDIR Tracker
- Voluntary recalls and maintained the recall tracker
- Implemented, monitored and managed ISO9001: 2008 (Continuous improvement)
- Conducted internal (all GE Healthcare Sites in Australia) and external audit (DHL Warehouse) by ISO9001
- Managed NCR/CAPA and audits in Trackwise
- Https://www.gehealthcare.com.au/
Cardinal HealthKings Langley, NSW
Quality Assurance Associate
02.2003 - 07.2005
Job overview
- Company Overview: https://www.medline.com.au/
- Implement, monitor and manage the Quality Management System as per ISO13485 2003
- Internal auditing to ISO 13485: 2003
- NCR, CAPA coordinator
- Customer complaint handling
- Review sterilization reports per batch
- Ensure products meet established quality standards and industry benchmarks
- Monitor processes and inspect produced goods and services
- Propose measures and process improvements to enhance operations, ensure the reliability of systems, and minimize downtime, errors, and defects
- Https://www.medline.com.au/
Jalco Cosmetics GroupHornsby, NSW
Quality Assurance Associate
10.2000 - 11.2002
Job overview
- Developed, implemented, monitored (audit) and managed QMS
- TGA GMP Pic/s compliant
- Supervised the QA analysts
- Conducted Internal audit
- Provided product complaint training
- Released finished products for distribution in compliance with standards
- Consulted with internal stakeholders and customers
- Batch release documents and inspections
- Performed complaint analysis reports as per company standards
- Prepared Dossier/ Tech file for Customers
- Developed, conducted, and evaluated quality audits and testing processes
- Established metrics for evaluating the effectiveness of quality assurance processes
- Review and approve CoA
- Verified quality control results with routine data and process audits
Pfizer PharmaceuticalsSydney, NSW
Stability & validation Chemist
05.1996 - 09.2001
Job overview
- Calibrated instruments for reliable chemical formulation and testing
- Conducted stability and validation testing as per BP Pharmacopeia validated testing methods
- Collated stability data and trending
- Non-conformance and CAPA management
- Comply to GMP Guidelines
- Troubleshot stability issues for new product development, product improvement initiatives and evaluations of individual ingredients
- Developed and optimized chemical procedures for manufacturing processes
- Prepared solutions, reagents, and solvents for laboratory experiments
- Provided technical support to sales teams by answering customer inquiries about product specifications or performance
- Analyzed samples using various analytical techniques such as chromatography, spectroscopy, and titration
- Reviewed scientific literature to stay current on industry trends and advancements in chemistry
- Maintained compliance with GMP requirements for optimal pharmaceutical industry manufacturing
- Evaluated product quality by conducting physical, chemical, and performance tests
- Trained junior chemists on laboratory techniques and best practices
- Maintained laboratory equipment and instruments for optimal performance
- Assessed chemicals using chromatography, spectroscopy and spectrophotometry
- Achieved precise and accurate results with tests by keeping equipment and instruments well-maintained
Timeline
QA and RA Specialist
Baxter Healthcare
09.2023 - 09.2024
ANZ QARA Lead
Owens & Minor Halyard Australia Pty Ltd
04.2019 - 08.2023
Regulatory Affairs Integration Consultant
Zimmer/Biomet Australia and New Zealand
02.2017 - 03.2019
Quality Assurance and Regulatory Affairs Manager
BioMérieux Australia Pty Ltd
08.2014 - 01.2017
Regulatory Affairs Associate (Medical Device)
Covidien Pty Ltd
04.2011 - 09.2014
Regulatory Affairs & Quality Assurance Associate
GE Healthcare Pty Ltd.
03.2005 - 08.2007
Quality Assurance Associate
Cardinal Health
02.2003 - 07.2005
Quality Assurance Associate
Jalco Cosmetics Group
10.2000 - 11.2002
Stability & validation Chemist
Pfizer Pharmaceuticals
05.1996 - 09.2001
Similar Profiles
Ismael CamarenaIsmael Camarena
Manufacturing Supervisor I at Baxter HealthcareManufacturing Supervisor I at Baxter Healthcare
Kevin KitchensKevin Kitchens
Associate Director, Implementation at Baxter HealthcareAssociate Director, Implementation at Baxter Healthcare
Kevin CarnesKevin Carnes
Pharmaceutical Territory Manager at Baxter HealthcarePharmaceutical Territory Manager at Baxter Healthcare
Christopher WeaverChristopher Weaver
Sr. Production Technician – Operational Excellence at Baxter HealthcareSr. Production Technician – Operational Excellence at Baxter Healthcare
Madhav DhakalMadhav Dhakal
Sustainability Engineer at CBRE – Sustainability ConsultingSustainability Engineer at CBRE – Sustainability Consulting