Qualifications and Experience

• Degree in Science, Pharmaceutical Science, Biotechnology, Microbiology, Chemistry, Food Science or a related discipline.
• Minimum 2 years' experience in a Quality Assurance or Quality Control role within a GMP-regulated environment.
• Working knowledge of GMP requirements, TGA regulations, PIC/S Guidelines and risk management principles.
• Experience within pharmaceutical, nutraceutical, complementary medicine or food manufacturing will be highly regarded.
• Experience with electronic quality management systems (eQMS) is advantageous.
• Environmental monitoring and audit experience is desirable.
• Knowledge of validation, change control and CAPA systems is preferred. 
• Tasks & responsibilities
• Prepare, review, issue and reconcile Batch Manufacturing Records (BMRs).
• Prepare Bills of Materials (BOMs), dispensing records and supporting production documentation.
• Ensure raw materials, packaging components and intermediate materials are approved and released before production.
• Review manufacturing documentation for compliance with GMP requirements.
• Support batch disposition and document management activities.
• Perform line clearance inspections during manufacturing and packaging operations.
• Conduct In-Process Quality Control (IPQC) checks across powders, capsules, tablets, liquids and specialty delivery systems.
• Support GMP compliance across production and warehouse operations.
• Perform environmental monitoring activities and trend environmental data.
• Generate environmental monitoring reports and investigate adverse trends.
• Manage and investigate deviations, CAPAs, change controls and risk assessments.
• Assist with root cause investigations and implementation of corrective actions.
• Support Product Quality Reviews (PQRs), audits and regulatory inspections.
• Maintain document control systems including SOPs, specifications, forms and quality records.
• Contribute to continuous improvement initiatives that enhance quality systems and operational performance.
• Coordinate quality activities across departments to support production schedules and customer requirements. 

Essential Skills 

• High attention to detail and strong organisational skills.
• Strong technical writing, documentation and record management capabilities.
• Excellent verbal and written communication skills.
• Ability to manage multiple priorities in a fast paced manufacturing environment.
• Proficiency in Microsoft Word, Excel and related software applications.
• A proactive, solutions focused approach to problem solving.
• Ability to work both independently and collaboratively within a cross functional team.
• Strong commitment to quality, compliance and continuous improvement.
• Positive attitude, strong work ethic and a desire to contribute to a growing business.
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