Senior QA Associate – Validation & Documentation Control
Position Title: Senior QA Associate – Validation & Documentation
Location: Sydney, Australia
Company Overview
We are a TGA GMP-licensed pharmaceutical and health supplement manufacturer specialising in the development and production of high-quality nutraceutical and healthcare products. Our facility manufactures a wide range of dosage forms including tablets, capsules, softgels, powders and liquids for both domestic and international markets. We are currently seeking a motivated and detail-oriented QA Officer to join our Quality team, primarily responsible for validation activities and quality documentation management.
Key Responsibilities
Validation Management
- Prepare, review and maintain validation documents including Validation Master Plans (VMP), protocols and reports for equipment, processes and cleaning.
- Execute and coordinate process validation, equipment qualification (IQ/OQ/PQ), cleaning validation and Computer System Validation (CSV), where applicable.
- Support validation related to new equipment installation, new product introduction and process changes.
- Ensure validation activities comply with TGA GMP, PIC/S guidelines and internal quality standards.
- Review validation data and ensure proper documentation and traceability.
SOP and Documentation Control
- Draft, review and maintain Standard Operating Procedures (SOPs) and other GMP documentation.
- Ensure all documentation complies with TGA GMP requirements and company quality systems.
- Manage document control processes including revision, approval, distribution and archival.
- Assist departments in developing and improving SOPs to ensure compliance and operational efficiency.
Quality System Support
- Support audits and regulatory inspections.
- Support deviation investigations, CAPA implementation and change control processes.
- Assist in maintaining and improving the Quality Management System (QMS).
- Provide QA guidance to production and technical teams to ensure GMP compliance.
Qualifications and Experience
- Bachelor's degree or higher in Pharmaceutical Science, Chemistry, Biotechnology, or a related scientific discipline.
- Minimum 2–3 years experience in a pharmaceutical, nutraceutical or related GMP regulated environment.
- Practical experience in validation (equipment, process, or cleaning) is highly desirable.
- Strong understanding of TGA GMP / PIC/S GMP guidelines.
- Experience in writing SOPs and quality documentation.
- Excellent attention to detail and strong documentation skills.
- Good communication skills and the ability to work collaboratively with cross-functional teams.
- Experience with TGA-licensed facilities or health supplement manufacturing will be an advantage.
Personal Attributes
- Strong organisational and analytical skills.
- Ability to manage multiple tasks and meet deadlines.
- Proactive attitude toward quality and compliance.
- High level of integrity and commitment to GMP standards.
What We Offer
- Opportunity to work in a TGA GMP licensed pharmaceutical manufacturing environment.
- Exposure to validation, quality systems and regulatory compliance.
- A professional and collaborative working environment with opportunities for career development.
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