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Quality Assurance Manager
2 months ago
Quality Assurance and Compliance Expert
Coadys Personnel Consultants is seeking a highly skilled and experienced Quality Assurance Manager to join our team. As a leading personnel consulting firm, we specialize in providing top talent to the medical and healthcare industry.
About the Role
This is a dynamic and challenging position that requires a passionate and knowledgeable QA professional with a minimum of 5 years experience in the medical/pharmaceutical sectors. The ideal candidate will have strong GMP and TGA knowledge, including compliance audits, and be an experienced team leader who can give clear direction and be hands-on when required.
Key Responsibilities
- Develop and maintain Quality Management Systems, Practices, and Plans to ensure the quality of all products meet GMP and TGA requirements.
- Perform release for supply of finished products as the authorized person.
- Foster collaboration between departments to ensure implementation of the QMS.
- Review and authorize change controls, deviation-motivated initiatives, and OOS's to ensure completion.
- Perform GMP compliance internal audits of facilities.
- Provide GMP training to staff and maintain an ongoing training schedule.
- Review and approve GMP agreements with customers and 3rd party manufacturers.
- Manage IQ/OQ/PQ qualification of equipment in production.
- Investigate customer complaints, initiate or recommend CAPA where required.
- Establish and ensure a validation plan that includes system, equipment, and instrument qualification and calibration.
- Evaluate batch records, coordinate, and control all activities of the QA department leading to the timely release and delivery of quality products according to established priorities and schedules.
- Act as the Product Recall Coordinator (liaise with the TGA, establish and maintain recall procedures, examine recall causes).
- Manage the preparation of SOP's and PQR's.
Requirements
To be considered for this position, you will be a tertiary qualified QA professional with a strong background in the medical/pharmaceutical sectors and have a valid driver's license. You will be required to live within a reasonable driving distance to the Northern Beaches.
