Sphere Healthcare is a leading contract manufacturer of Complementary Healthcare Products, based in Sydney with easy access to major motorways.
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.
Develop Specification and Regulatory documentation
Develop internal and external customer Specifications
Prepare master manufacturing and packaging Documents
Assist with the development of regulatory policies and procedures
Conduct material assessments to comply with quality standards
Participate in the planning and process flow of products through manufacturing
Provide technical/regulatory guidance and support to internal and external stakeholders
Skills & Experience:
A Bachelor of Science or equivalent in Chemistry
At least four years experience in the pharmaceutical or an allied industry
Working knowledge and ability to interpret Australian code of GMP and TGA regulations
Pharmaceutical formulation development
Knowledge of national & international pharmaceutical regulatory requirements
High level of attention to detail, initiative and strong work ethic
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. A strong awareness of Chinese culture and language would also be an advantage.
If you feel you have the above experience and skill set, submit your covering letter and resume via Seek.
Only applicants selected for interview will be contacted.
All other applicants are thanked for their interest.