Job Description
Are you passionate about quality plant-based medicines? We're seeking a Quality Officer to assist with a broad range of quality tasks relating to the supply of plant-based medicines. If you thrive in a fast-paced environment and enjoy driving high quality standards, this role is for you.
Your responsibilities will include working with the supply chain, operations, legal and regulatory teams to facilitate supplier onboarding, engagement with key external stakeholders who assist with manufacturing steps, and reviews of quality documentation. Ultimately, you will be pivotal in ensuring that all products released for supply conform with applicable standards and specifications.
The position will require an advocate for continuous improvement and will build upon existing processes that ensure the suitability, effective implementation, monitoring (for effectiveness) and maintenance of a compliant quality management system at Phytoca.
Further, the role will support Phytoca’s ongoing compliance with applicable quality standards including Good Manufacturing Practice and Good Warehousing Practice.
Reporting to the Head of Legal, your responsibilities will include:
Overseeing comprehensive quality control (QC) and quality assurance (QA) strategies and processes across the supply chain, including in relation to importation, cultivation, manufacturing, and product validation.
Ensuring compliance with all applicable quality regulations (e.g. GMP and labelling requirements under TGO +3) and internal quality specifications.
Supporting the introduction of new products by providing expertise in quality and compliance requirements.
Collaborating with the operations department to foster a culture of quality and compliance, driving continuous improvement and best practices in product delivery.
Conducting and reporting on regular audits and reviews to identify areas for improvement, ensuring corrective actions are implemented effectively.
Drafting quality related Standard Operating Procedures (SOPs).
Vetting product and packaging suppliers for quality related evidence.
Reviewing product labels for compliance approval.
Reviewing Certificates of Analysis provided by suppliers to confirm product conformance.
Preparing Certificates of Conformance for products to be released for supply to authorised customers.
Obtaining and maintaining auditable batch records.
Preparing and sending samples for third-party testing, including communicating with the third-party lab regarding any questions or concerns, and reviewing third party lab results.
Approving and releasing batches of products for supply.
Ensuring that retention samples from each batch of manufactured products are maintained.
Initiating recall protocols including mock recalls.
Investigating complaints related to the quality of the product.
Initiating Corrective and Preventative Actions (CAPAs) when investigating quality issues.
Reviewing and approving investigations (e.g. deviation, complaints and adverse events) and risk assessments. Where issues are deemed major or critical, escalating such issues appropriately.
Initiating audit programs (regulatory, internal and third party).
Maintaining the document management system and processes for the retention of records.
Facilitating supplier quality reviews and following documented procedures to ensure that service providers and outsourced activities are approved and monitored.
Facilitating and maintaining (where appropriate) material and product segregation and monitoring of storage conditions.
Managing quality issues relating to warehousing and distribution of scheduled medicines.
The ideal Candidate
A strategic thinker with a passion for excellence in product quality and compliance, as well as highly organised, with a keen attention to detail and a proactive approach to problem-solving.
Committed to fostering a collaborative and transparent workplace culture.
Your responsibilities will include working with the supply chain, operations, legal and regulatory teams to facilitate supplier onboarding, engagement with key external stakeholders who assist with manufacturing steps, and reviews of quality documentation. Ultimately, you will be pivotal in ensuring that all products released for supply conform with applicable standards and specifications.
The position will require an advocate for continuous improvement and will build upon existing processes that ensure the suitability, effective implementation, monitoring (for effectiveness) and maintenance of a compliant quality management system at Phytoca.
Further, the role will support Phytoca’s ongoing compliance with applicable quality standards including Good Manufacturing Practice and Good Warehousing Practice.
Reporting to the Head of Legal, your responsibilities will include:
Overseeing comprehensive quality control (QC) and quality assurance (QA) strategies and processes across the supply chain, including in relation to importation, cultivation, manufacturing, and product validation.
Ensuring compliance with all applicable quality regulations (e.g. GMP and labelling requirements under TGO +3) and internal quality specifications.
Supporting the introduction of new products by providing expertise in quality and compliance requirements.
Collaborating with the operations department to foster a culture of quality and compliance, driving continuous improvement and best practices in product delivery.
Conducting and reporting on regular audits and reviews to identify areas for improvement, ensuring corrective actions are implemented effectively.
Drafting quality related Standard Operating Procedures (SOPs).
Vetting product and packaging suppliers for quality related evidence.
Reviewing product labels for compliance approval.
Reviewing Certificates of Analysis provided by suppliers to confirm product conformance.
Preparing Certificates of Conformance for products to be released for supply to authorised customers.
Obtaining and maintaining auditable batch records.
Preparing and sending samples for third-party testing, including communicating with the third-party lab regarding any questions or concerns, and reviewing third party lab results.
Approving and releasing batches of products for supply.
Ensuring that retention samples from each batch of manufactured products are maintained.
Initiating recall protocols including mock recalls.
Investigating complaints related to the quality of the product.
Initiating Corrective and Preventative Actions (CAPAs) when investigating quality issues.
Reviewing and approving investigations (e.g. deviation, complaints and adverse events) and risk assessments. Where issues are deemed major or critical, escalating such issues appropriately.
Initiating audit programs (regulatory, internal and third party).
Maintaining the document management system and processes for the retention of records.
Facilitating supplier quality reviews and following documented procedures to ensure that service providers and outsourced activities are approved and monitored.
Facilitating and maintaining (where appropriate) material and product segregation and monitoring of storage conditions.
Managing quality issues relating to warehousing and distribution of scheduled medicines.
The ideal Candidate
A strategic thinker with a passion for excellence in product quality and compliance, as well as highly organised, with a keen attention to detail and a proactive approach to problem-solving.
Committed to fostering a collaborative and transparent workplace culture.
💡 Quick Summary
Seeking a career-building opportunity? The Quality officer position is now open for candidates interested in the IT Engineer & Developer Jobs sector. This role in Melbourne offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in IT Engineer & Developer Jobs is a plus.