QA Associate

About Sun Pharma ANZ Pty Ltd

Sun Pharma is the world's fourth-largest specialty generic pharmaceutical company, providing high-quality, affordable medicines trusted by healthcare professionals and patients in over 100 countries. In Australia and New Zealand, Sun Pharma ANZ Pty Ltd is a key player in the healthcare landscape, offering a diverse portfolio of products across various therapeutic areas. Our commitment to quality and compliance is the foundation of our success, and we are seeking a dedicated Quality Assurance professional to uphold these standards within our dynamic team.

Position Summary

We are seeking an experienced and meticulous Quality Assurance Associate to join our team in Sydney. In this pivotal role, you will be responsible for a wide range of GxP quality activities, ensuring that all products supplied in Australia and New Zealand meet the stringent local regulatory standards of the TGA and Medsafe, as well as Sun Pharma's global quality requirements.

You will act as a key quality point of contact, liaising with internal teams, international manufacturing sites, and regulatory bodies. This role is critical in ensuring the timely supply of safe and effective products to our patients.

Key Responsibilities

• Local Release for Sale:
  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.
• GMP Compliance & Incident Management:
• 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).
• 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 (PQC) Management:
  Oversee the end-to-end PQC process, from intake and investigation to trend analysis and reporting, ensuring timely closure and communication with stakeholders.
• Product Recalls:
  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.
• Local Rework & Relabelling:
  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.
• GMP Clearance Support:
  Collaborate with the Regulatory Affairs team to support
  TGA GMP Clearance applications
  for overseas manufacturing sites, providing necessary quality documentation and technical assessments.
• Product Quality Review (PQR) Oversight:
  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.
• Business & Project Support:
  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.
• Quality Agreements & Supplier Management:
• Draft, review, and maintain
  GMP Technical Agreements
  with contract manufacturers, 3PL providers, and other GxP vendors.
• Participate in the qualification and monitoring of local suppliers and service providers.
• Central Point of Contact:
  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 (QMS):
  Support the maintenance and continuous improvement of the local QMS, including document control, change control, training, and self-inspection programs.

Qualifications & Experience

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• A minimum of 2-3 years of experience in a Quality Assurance role within the pharmaceutical, biotechnology, or medical device industry in Australia.
• Demonstrated experience as an
  Authorised Person
  for product release under the Australian Code of GMP for Medicinal Products (PIC/S Guide to GMP).
• 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.
• Proven experience in managing quality deviations, complaints, and product recalls.
• Direct experience in
  liaising with the TGA
  on quality and compliance matters.
• Experience with GMP Clearance processes for overseas manufacturers.

Skills & Attributes

• Exceptional communication and interpersonal skills, with the ability to act as a credible
  focal point
  for all quality matters.
• Strong analytical and problem-solving abilities with meticulous attention to detail.
• Excellent organisational and project management skills, with the ability to manage competing priorities effectively.
• A proactive and pragmatic approach to quality management.
• Ability to work autonomously while also being a collaborative team player.

What We Offer

• A competitive salary package including superannuation and a performance-based bonus.
• Opportunity to work for a leading global pharmaceutical company with a strong local presence.
• A supportive and collaborative team environment that values quality and integrity.
• Professional development and career progression opportunities.
• Flexible working arrangements and a focus on employee well-being.