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Senior QA Associate – Herbal Medicines (The position has been filled)
Great opportunity to join a growing Tasmanian Herbal Medicines Manufacturer
Opportunity to take your career to the next level
Supportive and friendly work environment
Our client is a Herbal Medicines manufacturer based near Hobart. They are committed to producing & manufacturing the highest quality, affordable, medical grade therapeutic products for the Australian market. To their staff, they provide a supportive & close knit team environment where everyone is involved with a range of critical projects.
With new manufacturing facilities and a growing workforce, our client is currently undergoing the process of gaining a GMP manufacturing licence from the TGA. To achieve this, they require a Senior QA Associate to assist in developing and maintaining the necessary documentation required by the TGA. This position represents a rare opportunity for someone looking to progress their career as this young company continues to grow.
In broad terms, some of the duties associated with this role include:
Co-ordination of quality assurance practices and procedures
Continued development of existing Quality Manual and a Site Master File to obtain a TGA GMP manufacturing licence
Implement Quality Management System (QMS)
Assist Manufacturing Manager to develop manufacturing procedures
Update, complete and author Standard Operating Procedures for all processes
Preparation of any necessary quality, OH&S and other relevant procedures
Assist with obtaining and maintaining registrations with TGA
Once TGA approval has been granted, you will be expected to:
Manage the technical and regulatory aspects of the organisation, reporting to the Managing Director.
Collaborate and interact with partnering companies on new developments and other ongoing production issues that may arise.
Collaborate and interact with industry associates and government department officers.
Address any client queries on specific products.
Liaise with Regulatory consultants to manage requirements of the business.
Assure ongoing compliance with quality and industry regulatory requirements.
Develop, recommend and monitor corrective and preventative action.
Manage staff GMP training.
To be successful in your application you will need to meet the following criteria:
A Bachelor of Science, preferably in Pharmaceutical Science, Quality Assurance or related discipline
Previous experience working in a GMP quality environment with practical understanding of the requirements to the relevant guidelines and Codes of Practice as in GMP, ISO (e.g. TGA, PIC/S)
Experience in the Quality Management System (QMS) specifically in a pharmaceutical manufacturing environment will be highly regarded
Demonstrated ability to analyse data and arrive at sound, scientifically- based conclusions
Friendly personality and the ability to work in a small team.
Flexibility to adjust to changing needs and project strategies
Strong computer literacy skills
Ability to work autonomously as well as in a team environment
Excellent written and verbal skills
Excellent attention to detail
Well organised with the ability to meet deadlines.
To apply for this role, please click the ‘Apply Now’ button below and send your updated resume with a covering letter to CS Executive Group. For a confidential discussion about this role, please call our office on +61 3 9516 0100 during office hours and Helen +61 3 438 620 434 after hours
We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of candidates we receive on a daily basis, we can only contact those with suitable qualifications and experience. If on this occasion you are not successful, your resume will remain on our database and be considered for future suitable roles.