Summary
Overview
Work History
Education
Skills
Hobbies and Interests
References
Accomplishments
Certification
Timeline
Generic

Vanisha Seetal

Nunawading,Australia

Summary

I am a science professional with over 15 years’ experience in regulatory affairs, quality assurance and compliance in the pharmaceuticals industry. During the last 15 years of employment at the present company, I have successfully contributed to the growth of the business, assisting in the development and launch of over 50 consumer care products, whilst overlooking the compliance of the company’s product portfolio that includes cosmetics, complementary medicines, as well as medical devices for the Australian and export market. Graduating as a food scientist, I started my career in laboratory set-ups as laboratory technician/ food microbiologist in ISO 17025 accredited laboratories. I have also assisted the implementation and maintenance of HACCP in food businesses. I am confident that in FMCG organizations. I have consistently achieved 100% KPI Develop and maintain the highest standards of quality and compliance to support ensures that product release and associated quality assurance and compliance activities are completed with the highest level of care and accuracy I am results-driven, with excellent problem solving, innovation and critical thinking. Effective and efficient time management and organisational skills with the ability to prioritise and pivot to meet business needs and tight deadlines. Meticulous, proactive and keen eye for accuracy. Demonstrated leadership, multi-tasking and prioritising skills and total commitment to achieving excellence. Demonstrate a high level of analytical skills. collaborating with teams across various functions, fostering an environment of partnership building. In-depth knowledge of ANZ regulatory requirements for personal care, cosmetics, complementary medicines and low-risk medical devices. Extensive experience with product registration. Strong organisational skills with the ability to manage multiple projects and deadlines. The ability to work effectively in a cross-functional team environment. Familiarity with international regulatory requirements for personal care and cosmetics, especially within US and European regions. Strong attention to detail and ability to manage complex documentation and compliance requirements. Excellent communication skills, with the ability to interact effectively with regulatory bodies and cross-functional teams. Strong problem-solving and decision-making abilities. Skilled in Microsoft Office 365 applications including Word, Excel, PowerPoint, Outlook and SharePoint.

Compliance professional with extensive experience in regulatory adherence and risk assessment. Adept at fostering collaborative environments and driving compliance initiatives. Known for flexibility and reliability in dynamic settings, leveraging analytical skills and attention to detail.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Lead, Scientific Affairs & Compliance

LaCorium Health International/Australia Pty Ltd
05.2009 - Current
  • Ensuring compliance of product range with Cosmetic Standards, TGA regulations, AICIS, ACCC, Poison Standard (SUSMP) and ADG/Worksafe guidelines where applicable
  • Responsible for the preparation, maintenance and timely completion of regulatory documents to support regulatory compliance of company’s products across the Australia, New Zealand and International markets
  • Prepare regulatory submissions for TGA listing for the company portfolio including complementary medicines – topical and dietary supplements (Aust L), Aust R OTC drug, and Class I and IIa medical devices
  • Screen the compliance of European medical device manufacturers for compliance with the European medical device directives MDD 93/42/EEC and MDR
  • Manage the Quality Management System ISO 13485 for the medical device portfolio for supply in Australia and New Zealand, ensuring compliance with TGA and Medsafe regulations
  • Communicate with regulatory authorities to address TGA notices section 26A, 30 and 31 and resolve compliance issues
  • Prepare, manage and submit regulatory dossiers for product registration of cosmetic products for the international export market including the Middle Eastern countries, Canada, Asean, China and Israel
  • Keep abreast with industry trends, new regulations and changes in the regulatory landscape and provide insights and training across different business departments including sales and marketing
  • Plan and execute regulatory submission for cosmetics, drugs and natural health products regulated by Health Canada for export
  • Cosmetic Product listing under the recent FDA MOCRA regulations
  • Registration of FDA OTC drug for the USA market compliance during product life cycle
  • Maintain compliance of the sister company Every Bites Counts Pty Ltd with HACCP and Organic certification delivered by SGS and ACO respectively for subcontracted children’s snacks
  • Maintain processes and documentation including conduct internal audits and assist external certification audits
  • Conduct external GMP audits on primary subcontractors (manufacturers) and desktop audits of secondary subcontractors and 3PLs
  • Investigate customer complaints, non-conformances, deviations and general quality issues and execute CAPAs
  • Support customer service with feedback, investigations and resolutions
  • Responsible for Pharmacovigilance, reporting to management and head of technical department, assessing risk and reporting of adverse events to regulatory authorities for therapeutic goods
  • Responsible for quality assurance including product packaging, stability programs for the whole product range
  • Author product and packaging specifications, design validation exercise with contract manufacturing organizations and other GMP related requirements
  • Assess regulatory requirements for new products and provide input to regulatory strategies to management and marketing team
  • Conversant with the TGACC (advertising code)
  • Guide the marketing team and provide insight into acceptable claims for advertisements, training materials and modules
  • Address deficiencies raised by external stakeholders
  • Train staff on the internal quality management system and regulatory updates
  • Provide guidance, mentorship and support for team members
  • Prepare and maintain regulatory documents, including Product Information Files (PIFs) and Safety Data Sheets (SDS), stability programmes and validation requirements
  • Review and approve product labels, formulations, and supporting documents to ensure they meet relevant ANZ regulatory requirements
  • Gather and validate evidence to support product claims including literature review, peer-reviewed scientific papers, internationally recognised monographs and clinical evidence
  • Monitor regulatory trends and emerging issues, conducting product category research to assess risks and advising on appropriate mitigation strategies
  • Monitor and coordinate contractual agreements with relevant parties including subcontractors and external services providers

Laboratory Technician – Microbiology

EML Consulting Services
12.2008 - 03.2009
  • Microbiological testing of foodstuffs, pharmaceutical products and environmental samples
  • Perform testing, including set up, plate counts and subculture of pathogens according to ISO 17025 requirements

HACCP assistant

Jewel of India
11.2008 - 11.2008
  • Assist the Quality Assurance Manager in updating the HACCP manual: flow charts and product specifications of food products

Microbiologist

3M Microbiology Australia
07.2008 - 10.2008
  • Assist in the research and development of company products by performing microbiological experiments
  • Assist the improvement and verification studies on the Tecra-SAL-IC Unique plus instrument for rapid immunoassay-capture testing of Salmonella spp
  • Through experiments such as: effect of pH, salt concentration, time and temperature on instrument performance
  • Report results in a timely and scientific manner
  • Trained to abide by environment, health, safety and quality responsibilities

Laboratory Technician - Microbiology

SGS (Mauritius) Limited
06.2005 - 06.2008
  • Company Overview: (Multinational Societe General de Surveillance)
  • Acting Laboratory supervisor at the multinational consumer testing laboratory from Apr 2005 to Jun 2008
  • Participated actively in annual laboratory re-certificated ISO 17025 audits carried out by external accreditation body
  • Contributed in troubleshooting during setting up of test procedures, writing SOPs, Process flows and preparation for audits
  • Issued reports, supervised and trained four technicians in the microbiology laboratory, monitored tests, managed stock, ensured performance of tests according to ISO 17025 requirements
  • Participated in microbiological proficiency programmes
  • Conducted microbiological testing of foodstuffs, pharmaceutical products, environmental samples and livestock feeds based on internationally recognised procedures such as ISO protocols, APHA, AFNOR, AOAC and NMKL
  • Trained to perform tasks as per the requirements of the laboratory management system ISO 17025 including record keeping, monitoring of test procedures and equipment, and strict adherence to test procedures
  • (Multinational Societe General de Surveillance)

Student Work Experience Programme

Shandrani hotel (five star) – New Mauritius Hotels Limited
01.2004 - 03.2004
  • Assisted in the implementation and certification of food safety management system HACCP
  • Attended training sessions on food hygiene and HACCP provided by a food hygiene consultant

Student Work Experience Programme

Phoenix Beverage Group (Mauritius Breweries Limited)
01.2003 - 03.2003
  • Followed up on the fermentation and cold maturation of different types of beer
  • Evaluation of yeast response to stress, microbiological examination of water
  • Assisted sampling and quality control laboratory tests of raw materials and intermediate products
  • Assisted in implementation of good lab practices (GLP), good manufacturing practices (GMP), ISO 9001

Education

Bachelor of Science (Honours) - Food Science and Technology

University of Mauritius
01.2005

Higher School Certificate - Chemistry, Mathematics, Biology, General Paper (English), French

Dr Maurice Cure State Secondary School
11.2001

School Certificate - English, Mathematics, Additional Mathematics, Physics, Chemistry, Biology, Food and Nutrition

11.1999

Skills

  • 100% KPI achievement
  • Develop and maintain quality and compliance standards
  • Product release and quality assurance
  • Problem solving and critical thinking
  • Time management and organizational skills
  • Leadership and multi-tasking
  • Analytical skills
  • Knowledge of ANZ regulatory requirements
  • Product registration experience
  • Cross-functional team collaboration
  • International regulatory knowledge
  • Attention to detail
  • Microsoft Office 365 proficiency

Hobbies and Interests

  • Playing with and cuddling my children
  • Discovering the variety of food Australia has to offer
  • Unwinding with yoga

References

Available upon request

Accomplishments

  • Documented and resolved [Issue] which led to [Results].

Certification

Pharmacovigilance Professional

Advanced Advertising Code Course

Timeline

Lead, Scientific Affairs & Compliance

LaCorium Health International/Australia Pty Ltd
05.2009 - Current

Laboratory Technician – Microbiology

EML Consulting Services
12.2008 - 03.2009

HACCP assistant

Jewel of India
11.2008 - 11.2008

Microbiologist

3M Microbiology Australia
07.2008 - 10.2008

Laboratory Technician - Microbiology

SGS (Mauritius) Limited
06.2005 - 06.2008

Student Work Experience Programme

Shandrani hotel (five star) – New Mauritius Hotels Limited
01.2004 - 03.2004

Student Work Experience Programme

Phoenix Beverage Group (Mauritius Breweries Limited)
01.2003 - 03.2003

Higher School Certificate - Chemistry, Mathematics, Biology, General Paper (English), French

Dr Maurice Cure State Secondary School

School Certificate - English, Mathematics, Additional Mathematics, Physics, Chemistry, Biology, Food and Nutrition

Pharmacovigilance Professional

Advanced Advertising Code Course

Bachelor of Science (Honours) - Food Science and Technology

University of Mauritius
Vanisha Seetal