Senior Quality Associate

vor 3 Wochen


City of Melbourne, Österreich seek.com.au Vollzeit

Sypharma is an Australian specialty contract manufacturing group, motivated by a commitment to creating healthier futures. Since 2005 we’ve developed and manufactured therapeutic goods, veterinary products, and specialty consumer products. We’re a trusted partner and provider of biotechnology healthcare products in Australia and we partner to contract manufacture products for local and international markets. We are currently seeking a Senior QA Associate to join our team in Dandenong South. Reporting to Head of Quality and Regulatory Affairs, the successful applicant must have a (1-3) years’ experience working in a QA environment in the pharmaceutical sector. This is a fantastic role for someone within a pharmaceutical environment and is a great opportunity for career enhancement and skill set development or if you are looking at the next step in your career. About the role Reporting to the Head of Quality and Regulatory Affairs, you will be a key representative in the compliance of a pharmaceutical facility located in Melbourne. Additionally, you will support compliance activities related to various projects. Your main responsibilities will include, but are not limited to Leading maintenance of the QMS – internal audits, risk assessment, change control, CAPA, Deviations. Trending and investigational report writing. Leading PQRs. Assisting in management reviews. General maintenance of procedures (creation, review or approval) – SOPs, WIs. Overseeing training and vendor assurance management. Assisting in regulatory Audits. Batch review and release. Liaise with all relevant (Operations, R&D, etc) departments regarding quality related issues. Support the execution of the qualification and validation program for the facility. Work collaboratively with stakeholders for projects allocated including R&D, Validation, Engineering, Manufacturing, QA and QC staff and others to ensure the activities are planned and delivered in an efficient timeframe. Skills and experience A degree in a relevant science, with at least (3-5) years experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development. In-depth understanding of GMP requirements in the pharmaceutical industry and previous production, Quality or R&D experience within the pharmaceutical industry including qualification and validation principles and applications. Good interpersonal, negotiation and influencing skills. Good analytical and problem solving skills. Ability to work well independently and to self-motivate. Well-developed organizational and time management skills. #J-18808-Ljbffr



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