A regulatory scientist with a PhD in Microbial Ecology and nearly three years’ GMP reviewing experience and seven years’ Pharmaceutical Microbiology Quality Control (QC) experience, I wish to be considered for the Senior Microbiologist role (EL1, position No. 20031474) as recently advertised on your website. Please find below my skills and experiences relevant to the position. I have a broad range of technical and analytical skills in Microbiology and performing desktop research that I developed through accomplishing a PhD in Microbial Ecology and working in GMP and GLP accredited QC microbiology laboratories for over seven years. During my PhD, I acquired practical knowledge and experience in advanced microbiological techniques (e.g., PCR,
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I arranged this workshop based on the APVMA long-term objectives and the stakeholder’s expectations on the necessity of changes in Australian Veterinary Code of GMP .Upon approval from the delegate and being selected for organising the workshop, I discussed individual topics for presentation and draft agenda in a team meeting and requested the interest of my team members. I delegated tasks to other team members for technological aspects, accommodation, food, logistics and presenting different topics. I invited auditors and regulatory professionals for this workshop from the APVMA, Therapeutic Goods Administration and New Zealand Ministry of Primary Industries. During the workshop, I requested the invited professional to provide a regulatory update of their respective agency. On the day, we discussed on recent trends in therapeutic manufacturing, recent changes, common issues and how to resolve them. I was also aware that TGA had been adopting the most recent international manufacturing quality guidelines and requested TGA to provide an overview of how they have implemented the change and regulatory risk management that they have taken. Participants were segmented into discussion groups according to their expertise and were asked to identify any gaps in current veterinary manufacturing Code and the international guidelines. The groups were very enthusiastic and could identify some gaps between PIC/S guideline 2015 and current Australian Code of GMP and potential ways to resolve them within that small period. The findings from the workshop have led to the need for a full gap analysis. This gap has been noted in the business requirement for my section at the APVMA. I have been also actively engaged in conducting this gap analysis between the Pharmaceutical
I arranged this workshop based on the APVMA long-term objectives and the stakeholder’s expectations on the necessity of changes in Australian Veterinary Code of GMP .Upon approval from the delegate and being selected for organising the workshop, I discussed individual topics for presentation and draft agenda in a team meeting and requested the interest of my team members. I delegated tasks to other team members for technological aspects, accommodation, food, logistics and presenting different topics. I invited auditors and regulatory professionals for this workshop from the APVMA, Therapeutic Goods Administration and New Zealand Ministry of Primary Industries. During the workshop, I requested the invited professional to provide a regulatory update of their respective agency. On the day, we discussed on recent trends in therapeutic manufacturing, recent changes, common issues and how to resolve them. I was also aware that TGA had been adopting the most recent international manufacturing quality guidelines and requested TGA to provide an overview of how they have implemented the change and regulatory risk management that they have taken. Participants were segmented into discussion groups according to their expertise and were asked to identify any gaps in current veterinary manufacturing Code and the international guidelines. The groups were very enthusiastic and could identify some gaps between PIC/S guideline 2015 and current Australian Code of GMP and potential ways to resolve them within that small period. The findings from the workshop have led to the need for a full gap analysis. This gap has been noted in the business requirement for my section at the APVMA. I have been also actively engaged in conducting this gap analysis between the Pharmaceutical