QA/QC Officer (Meadowbrook)

As a QA/QC Officer at Breathe Life Sciences, you will play a crucial role in maintaining the highest standards of quality assurance and quality control across our manufacturing operations. Working closely with cross-functional teams, you will ensure compliance with regulatory requirements, industry standards, and company policies to uphold the quality, integrity and safety of our products. RESPONSIBILITIES
- Develop and implement quality assurance and quality control procedures to support the manufacturing of MDMA, Psilocybin, and cannabis products.
- Conduct risk assessments and identify areas for process improvement to enhance product quality, efficiency, and regulatory compliance.
- Perform batch record review, deviation investigation, and root cause analysis to identify and resolve quality issues in a timely manner.
- Collaborate with manufacturing, research and development, and regulatory affairs teams to support product development, scale-up, and commercialization activities.
- Conducting quality control inspections and tests on raw materials, in-process materials, and finished products to ensure compliance with established specifications and standards.
- Developing and implementing quality control procedures, protocols, and documentation to maintain compliance with regulatory requirements (e.g., TGA, EMA).
- Monitoring manufacturing processes to identify deviations, defects, or potential issues affecting product quality, and implementing corrective and preventive actions as necessary.
- Collaborating with cross-functional teams, including production, research and development, and regulatory affairs, to address quality-related issues and implement improvements.
- Investigating and documenting quality-related incidents, deviations, and non-conformances, and implementing corrective and preventive actions to prevent recurrence.
- Maintaining and updating quality control records, documentation, and reports in accordance with regulatory requirements and company policies.
- Keeping abreast of industry trends, regulatory updates, and best practices in pharmaceutical quality control to continuously improve processes and procedures.
- Upholding a culture of quality and compliance within the organisation through effective communication, training, and adherence to established standards. KEY REQURIEMENTS
- Bachelor’s degree or diploma in Chemistry, Microbiology, Pharmaceutical Science, or related field.
- Minimum of 1 year of experience in a pharmaceutical quality role.
- Knowledge of TGA regulations, GMP guidelines, and relevant pharmacopeial standards (e.g., USP, EP).
- Strong attention to detail and commitment to producing accurate, reliable results.
- Good organisational and time management skills.
- Effective communication and interpersonal skills for working within a cross-functional team.
- Ability to follow instructions, procedures, and regulatory requirements precisely.
- Ability to work independently with minimal supervision and thrive in a quick-paced, dynamic environment.
- Commitment to upholding the highest standards of quality, safety, and compliance in pharmaceutical manufacturing. Apply on Kit Job: kitjobau.com/job/3r29rs