An internationally recognised pharmaceutical company that produces many of the world's best-known consumer health care products, medicines and vaccines. Our Client is seeking an exceptional Quality Assurance Specialist to take on a role that offers a range of strategic and operational responsibilities in a dynamic, fast-paced environment.
Duties include but not limited to: Authorise the Release for Supply of productsReview batch manufacturing records for products released under the company licenseReview COA, COC, packaging artwork and any other relevant documentation of finished productsExecute, review and ensure any associated deviations are closedCompile Batch Release reports for submission to the TGA and liaise with the Regulatory Affairs to address TGA requests related to Annual Product Quality reports Review and approve documentation related to Release of Supply function as part of Marketing AuthorisationDevelop, review and prepare internal documents such as SOP's and create and review SCQ documents Carry out and assist in performing QRM assessments for changes and deviations as necessary, internal and external audits and review, create and approve GMP audit reportsContribute in trouble shooting investigations and lead quality risk assessmentsInitiate Continuous Improvement for processes and systems and take part in Action / Product Recalls
Ideally you will have: Tertiary qualification in ScienceA minimum 3 years' experience in a Quality Assurance roleSound experience and knowledge of GMP and regulatory requirementsGood understanding of Manufacturing processesAbility to work independently and in a team environmentStrong analytical, investigation, problem solving and decision making skillsStrong planning and organisational skills with the ability to multitask and follow tasks through to completionExcellent written and verbal communication skillsStrong attention to detail
If you meet the above requirements and are ready to join an organisation that improves the lives of people around the world and solves some of the world's most challenging healthcare problems, I would love to hear from you.
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Souraya Jumaah on 02 9432 3333.
To view all Techstaff job opportunities visit www.techstaff.com.au