Senior Quality Compliance Specialist

Senior Quality Assurance Associate Arrotex Pharmaceuticals is seeking a highly motivated and detail-oriented Senior Quality Assurance Associate to join our dynamic Scientific Affairs team. The Senior Quality Assurance Associate will work collaboratively with internal and external stakeholders to ensure that our products meet the highest standards, and that we meet our commercial obligations, while fostering a strong Quality Culture. This role will focus on quality risk management for our product quality complaints process and its various data and informational inputs and outputs in such a way that: Collected data is effectively analysed, measured against risk acceptance levels and reported to allow it to be raised to the levels of information, intelligence and knowledge to be used and retained for the benefit of the business, Appropriate complaint metrics and others are developed and reported on with a view to establishing our Key Performance Indicators, allowing for their management and improvement, The reports generated from this data are meaningful and useful to the business while also highlighting risks that may be faced by the business and Future preventative measures may be determined in relation to both product and supplier portfolios. Benefits and Culture: Competitive remuneration package Annual Bonus Structure Fantastic team culture Purchased leave scheme. Paid parental leave. Benefits/discount platform Novated car leasing Opportunity to advance your career with a growing team and company. Key Responsibilities: Perform risk assessment for product quality complaints and propose appropriate containment and disposition/escalation actions based on individual case risks considering how these may be affected by frequency and trend with their implications to both product and supplier portfolios Liaise with manufacturing sites to obtain and evaluate investigations Where risks exceed the risk threshold bring these to the attention of senior management Compile data with a view to developing this through to information, intelligence, and knowledge. Document the developed complaint knowledge so that it is retained as Intellectual Property for the benefit of the business. Develop and generate complaint and other metrics that are meaningful and useful to the business. Report monthly on the metrics developed to appropriate stakeholders as agreed and highlight critical issues. Conduct periodic reconciliation with suppliers and partners in relation to complaints recorded and their status. Works closely with Medical Information to triage, record & respond to enquiries. Established strong working relationships with the people & functions that provide data inputs and depend on the outputs of this role. Key Requirements 5 years’ experience in Quality Assurance, or a related technical or compliance role, in the pharmaceutical or medical devices industry. Experience supporting pharmaceutical manufacturing processes is highly desirable Tertiary qualification in Chemistry, Microbiology, Pharmacy, or a related Science or field is desirable. Strong problem-solving, critical thinking, and analytical skills, with the ability to investigate quality and compliance problems systematically and proactively, and to apply quality risk management principles to recommend workable outcomes; proactive anticipation of needs, with the ability to foresee challenges and problems, and take action to prevent them. Proven ability to interpret and apply GMP guidance, compliance policies and procedures, and risk management principles, providing sound and balanced recommendations to management. Demonstrates high levels of accuracy and attention to detail, with a focus on quality in all work and activities. Excellent/advanced written, verbal, and listening communication skills – produce well thought-out, professionally written correspondence free of grammatical and spelling errors; speaks with confidence, and clarity and is easily understood; active listening to effectively receive, interpret, and analyse information. Well-developed organisation and time-management skills with an ability to balance and prioritise a variety of tasks and competing demands, in order to manage workflow efficiently and meet critical time frames. Proven self-direction with the skills to be resourceful and the ability to exercise discretion and judgment in working independently and as part of a team. Skills in Microsoft Office 365 including Word, Excel, PowerPoint, Outlook, etc. Flexibility and a good sense of humour How to apply: If you are interested in this position, please click APPLY, or for a confidential discussion, please contact Sass Riechelmann – Talent Acquisition Business Partner, at sass.riechelmann@arrotex.com.au At Arrotex Pharmaceuticals, we are committed to creating an inclusive workplace that promotes and values diversity and inclusion. We believe in the diversity of our people across age, gender, identity, race, sexual orientation, ethnicity, and physical and mental ability. We strive on creating an equal employment environment where everyone from any background can be themselves. Arrotex acknowledges, and pays respect, to the Traditional Owners and ongoing custodians of the land.