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Are you experienced in pharmaceutical validation and thrive on achieving excellence in a dynamic environment? Do you deliver standout results first time, every time? If so, you’ll fit right in at Mayne Pharma. What’s in it for you? You’ll help us achieve our mission of delivering better, safer and more accessible medicines. At Mayne Pharma, the results speak for themselves About Mayne Pharma Mayne Pharma is a global pharmaceutical company offering end-to-end pharmaceutical development and manufacturing to customers around the world. Our heritage makes us one of the most well-known and respected pharmaceuticals companies in Australia. Mayne Pharma Australia are passionate about bringing globally valued pharmaceuticals to Australian patients and consumers. Our values of Passion, Integrity, Accountability, Creativity, Empowerment and Agility are the foundation for everything we do. Why Join Us? - Attractive remuneration packages
- Exclusive Health Insurance Benefits
Financial Flexibility - Well-being Programs
- Professional Development
- Mayne Perks: Enjoy exclusive discounts and savings
- Community Service
- Recognition and Team Events
- Health and Wellness
Your responsibilities, at a glance, will include: - Develop, execute and report on validation activities for manufacturing equipment, facilities, utilities, processes and cleaning systems.
- Prepare and maintain validation plans, protocols, reports and supporting documentation in accordance with cGMP and regulatory requirements.
- Support the planning and execution of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
- Coordinate and execute process validation, cleaning validation and equipment qualification activities.
- Conduct risk assessments for new and existing equipment, products and manufacturing processes.
- Analyse validation data, investigate deviations and recommend practical solutions to technical and compliance challenges.
- Collaborate with Production, Quality, Engineering and other stakeholders to coordinate validation schedules and ensure timely completion of activities.
- Support troubleshooting, periodic reviews, requalification and revalidation to maintain a compliant manufacturing environment.
- Maintain accurate validation records and documentation in accordance with regulatory and company quality standards.
- Identify and contribute to continuous improvement initiatives that enhance operational efficiency, quality and compliance.
You need to tick these boxes - We select applicants based on capability and aptitude, but we also place a strong emphasis on cultural fit.
- You'll bring a positive mindset, strong attention to detail and a proactive approach to problem-solving. You'll be comfortable taking ownership of your work while collaborating with others to achieve shared goals.
- To be successful in this role, you will also have:
- Tertiary qualifications in Chemical Engineering, Chemistry, Microbiology,
- Biotechnology or a related technical discipline, or demonstrated technical experience in a similar regulated environment.
- Experience in validation, qualification or technical activities within pharmaceutical manufacturing or another regulated industry.
- Knowledge of current Good Manufacturing Practice (cGMP) principles and an understanding of validation and regulatory requirements.
- Familiarity with equipment qualification, process validation, cleaning validation and validation lifecycle principles.
- Strong analytical and problem-solving skills, with the ability to identify practical solutions to technical challenges.
- Excellent written and verbal communication skills, with the ability to communicate effectively across all levels of the organisation.
- Strong organisational and time management skills, with exceptional attention to detail and accuracy.
- Competency in Microsoft Office applications, including Word and Excel.
- The ability to work autonomously while contributing positively to a collaborative, high-performing team.
- A flexible, adaptable and proactive approach to changing operational and business priorities.
Experience with FAT, SAT, IQ, OQ and PQ activities, together with mechanical aptitude and an understanding of evolving validation regulatory requirements, will be highly regarded. Ready to become part of the Mayne Pharma story? If you're passionate about quality, enjoy solving technical challenges and want to make a meaningful contribution to pharmaceutical manufacturing, we'd love to hear from you.
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