About Probiotec: Probiotec is a leading provider of contract manufacturing and packing services in the pharmaceutical and associated sectors, providing best-in-class solutions to a diverse range of clients. Since beginning operations in 1997, Probiotec has quickly emerged as a leading manufacturer and packer of a diverse, high-quality range of prescription ('Rx') and over-the-counter ('OTC') pharmaceuticals, complementary medicines and consumer health products.
The business is also one of Australia's largest packing companies, offering a multitude of packing services – including primary, secondary & co-packing capabilities as an end-to-end manufacturing and packing partner. With multiple sites across Australia including Multipack LJM, Southpack Laboratories, ABS, LJM and Probiotec Pharma, the group is responsible for employing over 1000 employees nationwide. As a leader in Australian manufacturing and packing services, Probiotec provides innovative healthcare products that improve the lives and well-being of our customers.
Your Role: The Quality Assurance Associate is responsible for overseeing the quality and maintain the ABS Quality System complying to TGA and client standards including document control, training, production quality, supplier quality and validation.
Main Responsibilities: Maintaining Quality Management System.Addressing and responding to client complaints.Addressing and responding to internal quality complaints (DRF's).Train employees on all Quality and PICS/GMP aspects.Assist in client and TGA (Regulatory) audits.Approve or reject, starting materials, packaging materials, and intermediate, bulk and finished products.Approve and monitoring of suppliers.Evaluate batch records.Ensure that all necessary inspections are carried out.Review / Approve specifications, sampling instructions, inspection methods and other Quality Control procedures.Approve any tests reports from third parties. (E.g. Calibration, Microbial and chemical).Prepare PQR reports.Check the maintenance of QA department, premises and equipment.Releasing Finished Goods to client or for Supply.Approve change controls.Perform qualifications and validations.Ensure retention samples are maintained in accordance with the labelling storage conditions.Additional Responsibilities & Tasks: Ensure adequate control of the manufacturing environment and plant hygiene.Ensure appropriate storage conditions for materials and products.Monitor compliance with the requirements of GMP.Knowledge, Skill & Qualification Requirements: Must have extensive experience in QA within manufacturing or packaging company in a therapeutic or allied industry.Complete knowledge of PIC/STeam building skills and ability to professionally lead and motivate team members.Contribute proactively to senior management.Show extensive knowledge and experience in management with Leadership skills within TGA licensed premises.Achieve agreed KPl's.Good written and communication skills and computing skills.Innovative in approach and problem solving.Ability to perform both individually and as part of a team.