The Junior Quality Associate – Validation is responsible for supporting validation activities across manufacturing, packaging, laboratory, and facility systems. This position will work closely with the Senior Quality Associate to support site validation plans and PQS compliance activities in alignment with TGA regulations, PIC/S GMP guidelines, and company SOPs.

Key Responsibilities:

Develop, and execute validation protocols and reports for equipment, facilities,utilities, cleaning, processes, and computerized systems in line with regulatory expectations.

Ensure validation activities align with current TGA, PIC/S GMP, and ISO guidelines applicable to complementary medicines and probiotics.

Collaborate with cross-functional teams (Production, QC, Engineering, R&D) to plan and coordinate validation projects and ensure timely completion.

Maintain the site Validation Master Plan (VMP) and ensure it is current and reflective of site operations and risk-based strategies.

Manage requalification and periodic review schedules for equipment and processes.

Provide technical input during equipment commissioning and change control assessments.

Support site readiness for internal, TGA, and third-party audits.

Support Quality Assurance activities.

Maintain good documentation practices (GDP) and ensure timely data entry and reporting.

Key Relationships:

Quality Assurance

Quality Control

Manufacturing and Packaging Operations

Qualifications & Experience:

Essential:

Bachelor’s degree in Microbiology, Chemistry or Biotechnology, or related field.

Minimum 2 years experience in a GMP-regulated manufacturing operation.

Sound knowledge of PIC/S Guide to GMP, TGA regulations, and Australian regulatory environment for complementary medicines.

Ability to write and review technical documents.

Desirable:

Experience in a probiotic manufacturing facility.

Exposure to computer systems validation (CSV) and data integrity principles.

Key Competencies:

High attention to detail and documentation accuracy.

Good analytical and problem-solving skills.

Effective written and verbal communication.

Ability to manage multiple tasks and priorities.

Collaborative team player with a proactive mindset.

Performance Measures:

Compliance with internal SOPs and regulatory requirements.

Timely completion of assigned tasks.

Audit readiness and minimal audit findings.

Work Environment:

This role is primarily site-based, operating within office and GMP facility environments. Occasional extended hours may be required.