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