Pharmaceutical Quality Assurance Specialist

We are seeking an experienced Quality Assurance Specialist to join our team in Sydney. This pivotal role involves ensuring that all products supplied in Australia meet the stringent local regulatory standards and our company's quality requirements.

• Product Release Management: Act as an Authorised Person for the final disposition of imported therapeutic goods, performing batch review and release for sale in Australia in accordance with TGA requirements and local procedures.
• Quality Deviation Resolution: Contribute to the investigation and resolution of GMP non-compliance issues, deviations, and out-of-specifications (OOS) results. Develop and implement effective Corrective and Preventive Actions (CAPAs).
• Regulatory Liaison: Act as the primary quality liaison with the TGA and Medsafe regarding quality defects, GMP non-compliance, and other significant quality matters.
• Product Quality Complaint Management: Oversee the end-to-end Product Quality Complaint (PQC) process, from intake and investigation to trend analysis and reporting, ensuring timely closure and communication with stakeholders.
• Recall Coordination: Manage and coordinate all aspects of local product recalls, from initiation and risk assessment to execution and reporting to the TGA/Medsafe, ensuring compliance with Australian recall procedures.
• Third-Party Logistics Oversight: Manage and provide quality oversight for any local rework, over-labelling, or repackaging activities performed by third-party logistics (3PL) providers, ensuring full GMP compliance.
• Regulatory Affairs Support: Collaborate with the Regulatory Affairs team to support TGA GMP Clearance applications for overseas manufacturing sites, providing necessary quality documentation and technical assessments.
• Annual Product Quality Reviews: Review Annual Product Quality Reviews (APRs/PQRs) provided by manufacturing sites, ensuring all local commitments and regulatory requirements are met, and summarising key data and trends for local management.
• QA Expertise: Support key business requirements from a QA perspective by providing expert guidance on new product introductions, technical transfers, and other commercial projects to ensure seamless, compliant execution.
• GMP Technical Agreements: Draft, review, and maintain GMP Technical Agreements with contract manufacturers, 3PL providers, and other GxP vendors.
• Internal and External QA Discussions: Serve as the focal point for internal and external QA discussions, providing expert guidance to Supply Chain, Regulatory Affairs, Medical, and Commercial teams, as well as to international quality counterparts and third-party partners.
• Quality Management System Maintenance: Support the maintenance and continuous improvement of the local Quality Management System (QMS), including document control, change control, training, and self-inspection programs.

Our ideal candidate will possess the following qualifications and skills:

• Education: Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• Experience: Minimum of 2-3 years of experience in a Quality Assurance role within the pharmaceutical, biotechnology, or medical device industry in Australia.
• Authorised Person Experience: Demonstrated experience as an Authorised Person for product release under the Australian Code of GMP for Medicinal Products (PIC/S Guide to GMP).
• TGA Regulations Knowledge: In-depth, practical knowledge of TGA regulations, the Therapeutic Goods Act 1989, and PIC/S GMP guidelines. Experience with Medsafe (NZ) regulations is highly advantageous.
• Quality Management Skills: Proven experience in managing quality deviations, complaints, and product recalls.
• Communication Skills: Excellent communication and interpersonal skills, with the ability to act as a credible focal point for all quality matters.
• Analytical and Problem-Solving Skills: Strong analytical and problem-solving abilities with meticulous attention to detail.
• Organisational and Project Management Skills: Excellent organisational and project management skills, with the ability to manage competing priorities effectively.

We offer a competitive compensation package, opportunities for professional growth and development, and a dynamic work environment.

To apply for this exciting opportunity, please submit your resume and cover letter.