We are currently seeking a Degree qualified Regulatory Affairs Officer to join our Technical Department on a full time basis. The candidate will be responsible for the preparation of specifications, manufacturing and packaging documentation to meet all the required GMP and TGA regulatory standards. Individuals looking to apply must be reliable, punctual self starters motivated by team work.
Ø Develop Specification and Regulatory documentation
Ø Develop internal and external customer Specifications
Ø Prepare master manufacturing and packaging Documents
Ø Assist with the development of regulatory policies and procedures
Ø Conduct material assessments to comply with quality standards
Ø Participate in the planning and process flow of products through manufacturing
Ø Provide technical/regulatory guidance and support to internal and external stakeholders
Applications are welcome from individuals with the following:
Ø A Bachelor of Science or equivalent in Chemistry
Ø At least four years experience in the pharmaceutical or an allied industry
Ø Working knowledge and ability to interpret Australian code of GMP and TGA regulations
Ø Pharmaceutical formulation development
Ø Knowledge of national & international pharmaceutical regulatory requirements
Ø High level of attention to detail, initiative and strong work ethic
Ø Excellent English skills to produce written documents
Ø Self starters able to work on their own or as part of a team to achieve challenging deadlines
Good written and verbal communication skills together with knowledge of basic computer word processing, spreadsheets, MRP and SAP software systems could make you the successful candidate for this role.
We are looking to fill this role as soon as possible. If you have relevant experience this is a great opportunity to work in a supportive and friendly environment for a well-established company, please forward a resume and covering letter to:
Mail: Human Resources
Sphere Healthcare Pty Limited
P O Box 566, Moorebank NSW 1875
Fax: +61 2 9822 7100
Please note that we will only contact applicants that meet our criteria for interview.