Senior QA/Regulatory Affairs Associate

Star Combo Australia; Sydney; On-site; AUD 85,000 - 110,000; Full time

Job summary

Star Combo Australia, Sydney-based manufacturer, seeks a Senior QA/Regulatory Affairs professional to lead regulatory activities and ensure GMP compliance across processes and systems.

You will review labels and promotional materials, coordinate ARTG registrations, and support Sales/Production with technical quality tasks, while maintaining licenses and validation programs essential to compliance.

Qualifications

• Bachelor or equivalent in science/engineering.
• 2+ years in Regulatory Affairs or QA in a related industry.
• Knowledge of Australian TGA regulations and HACCP principles.
• Experience with product registration and ARTG listing processes.

Responsibilities

• Handle senior QA/regulatory affairs activities for the Sydney site.
• Provide regulatory input into premarket, postmarket and business activities.
• Review labelling, packaging and promotional materials for compliance.
• Coordinate product registration processes including ARTG listing submissions.
• Develop templates for quality and technical documentation in GMP compliance.
• Maintain quality systems and ensure GMP compliance across operations.
• Support Sales/Production/Operations with technical and quality issues.
• Maintain licenses and MVP programs including IQ/OQ/PQ and cleaning validations.

Skills

Regulatory Affairs

Quality Assurance

GMP compliance

HACCP understanding

Labelling & packaging review

Education

Bachelor of Science or Engineer or equivalent

Job description

The primary objective of this position is to facilitate Sydney based complementary manufacturer in their relevant processes and systems to comply with local regulatory requirements and relevant authority in Australia.

Core Job Responsibilities:

• Senior QA/Regulatory Affairs related activities.
• Provide regulatory input into premarket, post market, and business activities as required, respective to assigned portfolios.
• Review labelling, packaging, and promotional materials for compliance with regulatory standards.
• Coordinate / perform / assist with product registration process include research therapeutic functions of new products and prepare and submit ARTG listing application.
• Create templates for Quality and technical documentation and ensure compliance with GMP regulations
• Meet the requirementstoCode of GMP by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
• Establish and maintain specifications and standards for control of raw material; packaging and finished products.
• Manage/coordinate company quality system.
• Coordinate / perform / assist with product registration process include research therapeutic functions of new products and prepare and submit ARTG listing application.
• Support other departments on technical and quality issues especially Sales / Production / Operations departments.
• Maintain existing licenses and acquire required licenses/certificate as needed.
  
• Maintain the company MVP programs include carry out IQ/OQ/PQ, process validation and cleaning validations.

Knowledge / Education Required:

Minimum Bachelor of Science or Engineer or equivalent.

Experience Required:

• Hand on experience required in Regulatory affairs to perform this job.
• Must have been a quality with QA experience or Regulatory Affairs associate in complementary industry with minimum 2 years’ experience.
• KnowledgeofAustralian Health AuthorityTGAregulationsa must with understanding of basic principles in HACCPpreferable.
• Preference will be provided to candidates with previous experience in a complementary manufacturing facility.