Authorised Person Job Description
We are seeking an Authorised Person to join our Quality Assurance team at a site in Carole Park.
Key Responsibilities:
* Release finished product manufactured for the Australian market, in accordance with procedures, Marketing Authorisations and applicable regulatory guidelines.
* Release of bulk product and finished product to export markets in accordance with procedures, Marketing Authorisations and applicable regulatory guidelines.
* Ensure that all raw materials, packaging materials and bulk products are released in accordance with specifications and procedures.
* Review deviations (incidents and investigations), CAPA's, Effectiveness Checks and complete trending for all deviations (incidents and investigations), raise Trend Assessments and attend the Trend Review Board meetings.
* To ensure master batch manufacturing and packaging documents as well as SAP recipes are complete and correct and to approve these for use.
* Support and encourage continuous improvement initiatives for the benefit of the Quality department and the wider business.
* Provide support to manufacturing, packaging and maintenance regarding any queries relating to quality matters.
* Approve Annual Product Quality Reviews.
Requirements:
* Tertiary qualification in Science or related field.
* Minimum 5 years' experience in the Pharmaceutical Industry.
* Understanding of GMP and regulatory requirements.
* Excellent communication and organisation skills.
* Experience with writing reports and presenting data.
* Demonstrated attention to detail.
* Proven ability to work under minimal supervision.
* Must be eligible to work in Australia.
Why This Role?
This is an excellent opportunity to advance your career in quality assurance. You will have the chance to develop your skills and knowledge in a dynamic environment, working closely with a team to ensure the highest standards of quality.
We are looking for a highly motivated and organized individual who is passionate about delivering high-quality results. If you are a driven professional with a strong work ethic, we would love to hear from you.
Please note that this job description is subject to change based on the company's needs.