Based St Leonards with flexible working arrangements.
Aspen Australia is one of the largest pharmaceutical companies in Australia. We have built a portfolio of iconic brands in the prescription and OTC markets, and are the market leaders in many categories. We're a business inspired to make a difference to individual lives by providing quality, affordable medicines and healthcare products.
Senior QA Associate
Reporting to the Quality Manager, you will be responsible for ensuring quality assurance activities are adhered to, to guarantee our consumers receive quality products, which meet industry standards.
Specific areas of accountability will include:
* Liaising with manufacturers, distributors and Aspen stakeholders to address issues pertaining to the quality of all Aspen product.
* Obtaining and reviewing release documentation, retention sample and artwork verification and temperature data during transportation verification.
* Performing 'Release for Distribution' and notifying the warehouse of batch disposition.
* Conducting quality related activities such as sample release, and SOP drafting and review as required.
* Ensuring quality concerns are addressed in a timely manner, initiating and writing deviations, conducting investigations and performing root cause analysis.
* Providing support for the change control system, liaising with appropriate personnel for the regulatory impact assessment and conducting the quality impact assessments.
* Developing and maintaining periodic reviews of the Product Quality Review reports, liaising with regulatory departments for completion of the review of marketing authorisation and identifying trends and making recommendations for CAPAs in consultation with manufacturers/suppliers.
* Participation in internal and external quality audits (as required).
* Support of other quality related activities on an 'as needs' basis, such as quality complaints, CAPA.
What we are looking for:
* Tertiary qualifications in a science or related field preferred but not essential.
* Previous QA experience (10 years +) within a pharmaceutical environment is preferred, with a thorough working knowledge of GMP.
* Knowledge of PICS and cGMP requirements.
* Strong and clear communication skills (verbal and written) and relationship building skills.
* Experience dealing cross functionally with supply chain and regulatory affairs.
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