Andrew Giles Email & Phone Number

Consulting and industry training in the areas: Computer system Validation (CSV), Good manufacturing Practice (GMP) and Good Laboratory Practice (GLP) compliance consulting to TGA, EU and FDA requirements; Quality Management Systems documentation preparation;Gap analysis and auditing;GMP, GLP, Validation (including CSV) training at enterprise and public.

Melbourne, Australia

GMP Auditor/Inspector medicines in the Therapeutic Goods Administration (TGA).The role involves the inspection of pharmaceutical manufacturing and testing facilities and associate quality systems on behalf of the Australian Federal Government.

This position was for additional duties in conjunction with normal inspection duties with OMQ. It involved coordinating the training of Inspectors as well as the development of internal quality systems.

Manage the IT Compliance department (QA), which includes four IT Compliance Associates. The position reports to the Quality Assurance Manager at Mulgrave.The department was responsible for ensuring that automated systems within Mayne Asia Pacific comply with the pharmaceutical regulations for automated systems including the 21st Code of Federal Regulation.

The role involved the management of the IT Systems Development Department, which includes four Programmer/Analyst, two IT Compliance Officers and one Documentation officer. The role also requires the management of contract and consultant staff.The department is responsible for ensuring that automated systems within Mayne Asia Pacific comply to the.

The role starting in F.H. Faulding before the company was acquired by Mayne Pharma in 2001.Responsibilities:Manage the Quality Assurance (QA) SystemsDevelopment Department, which includes two full time Programmer/Analyst and one contract compliance consultant.The department designs, supports, documents and validates internally designed automated (computer.

It was the responsibility of the "Challenge 2000 Site Coordinator" to ensure that all automated systems on the Mulgrave site were year 2000 compliant before the end of 1999.Responsibilities:To ensure the continuity of date related automated (computer-based) equipment from 1999 to the new century/millennium. Key Achievements:The Mulgrave site was repeatedly.

Responsibilities:Managed three Chemists.The department was responsible for R&D related projects often involving new container systems. The Project Services Department was required to liaise with many other departments to facilitate the effective management of projects. The Department was involved with headspace gases in vials, freeze drying, innovative.

Responsibilities:New container closure development, production trouble shooting and tackling the difficult product development problems that were beyond the bounds of the normal R&D group.Key Achievements:The department consisted of only two people. We successfully introduced shrink wrapping into the entire range of vials at the Mulgrave site.

The role started in DBL which was wholly owned by F.H. FauldingResponsibilities:The department was responsible for overseeing the development of new generic parenteral products. The Job involved close liaison with Regulatory Affairs Department while coordinating studies in the R&D laboratory, assigning stability date, coordinating new product launches and.

Responsibilities: Design and operation of a production facility for veterinary products based at Noble Park in Victoria.6 months was spent in Deeside Wales (United Kingdom) developing new sustained release oral dose veterinary products. The role included the overseeing of pilot scale manufacture of oral dose veterinary products on fluid bed spray coating.

Responsibilities:Responsible for the transfer of technology from Research and Development to the manufacturing operations. Also responsible for process validation and trouble shooting. Key Achievements:The position was newly created when I took on the role. I established standards in validation and analysis for the Pellet Products Department at Salisbury.

Responsibilities: The role was that of a Development Chemist working on new sustained released oral dose Pharmaceutical's.

Mobil Birkenhead oil terminal S.A.Responsibilities:Responsible for the routine testing of oils and fuels

ICI OsborneResponsibilities:Collect plant samples. Analysis of theammonia and chloride levels in plant samples

Graduate Diploma In Computing, Computing By Distance Education

Graduate Diploma in Computing

Bachelor Of Applied Science, Chemistry/Microbiology

Bachelor of Applied Science in Chemistry/Microbiology