Sun Pharma Hiring Life Science Graduates | Apply Now for Quality Assurance Associate Role
Sun Pharma, one of the worldโs largest specialty generic pharmaceutical companies, is seeking a Quality Assurance (QA) Associate to join its team in Sydney, Australia. In this pivotal role, you will oversee GxP quality activities, ensure compliance with TGA and Medsafe regulations, and act as a key quality liaison across internal teams, regulatory bodies, and international manufacturing sites. This is a unique opportunity to contribute to the timely delivery of safe and effective medicines while growing your career with a global leader in healthcare.
- Job Position: Quality Assurance Associate
- Location:ย Sydney, Australia
About the Company
Sun Pharma is the worldโs fourth-largest specialty generic pharmaceutical company, delivering trusted, high-quality, and affordable medicines to healthcare professionals and patients in over 100 countries. In Australia and New Zealand, Sun Pharma ANZ Pty Ltd plays a vital role in the healthcare system, offering a wide range of products across therapeutic areas. With a strong focus on quality and compliance, Sun Pharma continues to grow as a leader in the pharmaceutical industry.
QA Job Description
As a QA Associate at Sun Pharma, you will manage a wide range of GxP quality activities to ensure products supplied in Australia and New Zealand meet strict TGA and Medsafe standards, as well as Sun Pharmaโs global quality requirements. You will act as an Authorised Person for batch release, oversee compliance matters, and serve as a primary quality liaison with regulatory authorities.
Key Responsibilities
- Act as an Authorised Person for the final disposition and release of imported products in line with TGA requirements.
- Investigate GMP non-compliance issues, deviations, and OOS results; develop CAPAs.
- Serve as the key liaison with TGA and Medsafe on quality and compliance issues.
- Manage Product Quality Complaints (PQC) and oversee product recalls.
- Provide quality oversight for local rework, relabelling, and third-party logistics (3PL) activities.
- Support TGA GMP Clearance applications for overseas sites.
- Review Annual Product Quality Reviews (PQRs) and report local trends.
- Draft, review, and maintain GMP Technical Agreements with suppliers and 3PLs.
- Act as the central point of contact for QA with internal and external stakeholders.
- Support and improve the Quality Management System (QMS), including training, document control, and self-inspection programs.
QA Job – Educational Qualification
Bachelorโs degree in Life Sciences, or related field.
Experience and Skills
- Minimum 2โ3 years of QA experience in the pharmaceutical, biotechnology, or medical device industry in Australia.
- Experience as an Authorised Person for product release under PIC/S GMP.
- Strong knowledge of TGA regulations, the Therapeutic Goods Act 1989, and PIC/S GMP guidelines.
- Advantageous: Experience with Medsafe (NZ) regulations and GMP Clearance processes.
- Proven track record in managing deviations, complaints, and product recalls.
- Experience liaising directly with the TGA on compliance matters.
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving ability.
- Highly organized with practical project management skills.
- Proactive and pragmatic approach to quality management.
- Ability to work independently while collaborating across teams.
Keywords: Sun Pharma, QA Associate, Quality Assurance job, Sydney, pharmaceutical industry, TGA regulations, GMP Compliance, Quality Management System, Career opportunities
