Senior Quality Assurance Associate
Aegros Therapeutics Pty Ltd, Australia
Job Description
About Aegros
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collect into life saving hyperimmune products.
About the role
We are seeking a trained person to join our quality assurance team to perform a range of tasks including:
- Perform full spectrum of functions of Quality Associate role.
- Support the QA Manager in the set-up and maintenance of QMS.
- Ensure QMS and operational compliance with regulatory requirements.
- Support for key QMS systems such as audits, CAPA, SOP review, etc.
- Support RA activities.
- Support in developing and implementing quality strategies.
- Deviation and complaint management, Products and Materials Release, Validation and Change Control Support, New production introduction and Documentation Controls to ensure an efficient operational Quality System that assures full compliance with company policies, regulatory requirements and cGMP
- Responsible for ensuring that material supplied is fit for purpose for customer
- Responsible for providing quality oversight for Operations activities
- Support the QA Manager in continuous improvement projects and quality related improvement initiatives.
- Assist in internal audits and the review of validation reports
- Issue and review batch documentation and release of batches of Intermediate, Bulk and Finished products
- Supervise in the preparation of annual product quality reviews.
- Other duties as assigned
Agencies please note: this recruitment assignment is being managed directly by Aegros. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated.
Requirements
To be the successful applicant for this great opportunity you will be tertiary qualified in biological science or related discipline with at least 4 years commercial GMP experience in QA. Previous experience in the pharmaceutical or equivalent industry and in the assessment of deviations, change controls and CAPAs is a must.
You must be able to communicate well in spoken and written word and be a highly motivated and pro-active self-starter.
If you have the skills and experience to successfully carry out the requirement of the role, we would like to hear from you!
Apply now via SEEK for this great opportunity, including your CV!
Benefits
- Supportive and friendly team
- Access to on going training and development opportunity
- Rewarding culture
- Weekly Fruits
- Birthday Celebration