Scientific Quality Manager
Vor 6 Tagen
Scientific Quality Manager – Slade Health Location: Mt Kuring‑gai, NSW (hybrid position available for the right candidate) Job type: Permanent Full Time Hours: 76 hours per fortnight About Slade Health Slade Health is a leading provider of aseptically compounded chemotherapy, antibiotics, parenteral nutrition and analgesic medicines. We operate GMP licensed manufacturing facilities in Australia and New Zealand. Our laboratory undertakes stability studies to support the extension of product shelf‑life, enabling patients to be treated with cutting‑edge medicines closer to home. Key Responsibilities Maintain quality oversight of the Scientific department and laboratory activities to ensure GMP compliance and high standards of quality are maintained, including for physicochemical and biological stability studies of compounded medicines, testing of environmental samples from the manufacturing environment, and investigational testing. Have responsibility for the laboratory’s GMP licence and other accreditations, permits and licences held by the laboratory. Work closely with the principal scientist to ensure Slade Health’s scientific activities and the laboratory comply with regulatory expectations and Slade Health’s pharmaceutical quality system. Be involved in and have quality oversight of scientific studies, testing activities and compounded product assessment. What We Are Looking For A good knowledge of Good Manufacturing Practice and PIC/S. Experience driving quality in a GMP‑licensed environment or equivalent. Strong knowledge of pharmaceutical quality systems, including document control and training; non‑conformance, deviations and complaints; risk management, CAPA and change control; validation and supplier management; continuous improvement and audit programs. Strong analytical skills and experience managing data sets. Knowledge of biological molecules such as monoclonal antibodies and antibody‑drug conjugates. Familiarity with methodologies such as HPLC, CE, ELISA, protein‑binding assays, etc. Understanding of stability study design principles. Previous laboratory experience is desirable. Advanced skills in MS Excel, intermediate MS Office suite skills. Ability to communicate effectively with peers, management, suppliers and regulatory bodies. Strong task and time‑management skills; ability to coordinate, track and prioritise tasks to deliver to tight timeframes. How to Apply Please apply by clicking the Apply link and attaching a covering letter and resume. If you meet the requirements, we look forward to hearing from you. #J-18808-Ljbffr
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Scientific Quality Manager
vor 2 Wochen
Council of the City of Sydney, Österreich Icon Group VollzeitQuality and Safety Sydney Full Time Slade Health Scientific Quality Manager – Slade Health Be part of Slade Health’s established Quality Assurance team, working in a dynamic and supportive work environment Maintain quality oversight of Scientific department and Laboratory activities to ensure GMP compliance and high standards of quality are maintained,...
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Scientific Quality Manager
vor 4 Stunden
Council of the City of Sydney, Österreich Slade Health VollzeitScientific Quality Manager – Slade Health Quality and Safety Sydney Full Time Slade Health Be part of Slade Health’s established Quality Assurance team, working in a dynamic and supportive work environment Maintain Quality oversight of Scientific department and Laboratory activities to ensure GMP compliance and high standards of quality are maintained,...
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