Ph3Position Purpose /h3 pThe Senior Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical Development portfolio. /p pTo do this, the GMP Site Quality Associate has the primary purpose of ensuring compliance with GMP/GSP/GxP by providing front‑line quality guidance and support across all phases of Technical Product Development. You will also ensure self‑inspections are conducted and followed up in a timely manner and provide quality and compliance support throughout all aspects of technical product. /p h3Main Responsibilities and Accountabilities /h3 ul liParticipate in IPT Project and associate delivery team meetings, providing quality/compliance leadership, guidance and advice /li liManage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required /li liManage and facilitate the deviation meeting process, manage deviations to closure, including significant and complex deviations, to ensure that information recorded is comprehensive and remedial actions are appropriate and executed in a timely manner /li liFacilitate change panel meetings, manage change controls to completion, including significant and complex changes, to ensure changes are appropriate and comply with regulatory requirements /li liLiaison with Technical departments for quality assurance and compliance related issues /li liManage Product Technical Complaints and associated investigations /li liReview and approve Technical Document Change Requests /li liConduct self‑inspections, provide reports in a timely manner, assess responses and provide quality advice to maintain regulatory compliance and continuous improvement /li liProvide training in QMS principles as required /li liParticipate in updating of QA documents as relevant to Technical Development /li liProvide QA compliance review and approval of relevant product documents /li liAttend and manage Quality Risk Assessments (QRAs) as required /li liEducate technical staff in GxP and quality system requirements /li liEstablish and maintain local and global product‑related Quality Agreements /li /ul h3Position Qualifications and Experience Requirements /h3 h3Education /h3 pA degree in a relevant biological science, with at least 3 years’ experience in at least one of the following areas: Manufacturing under GMP, Regulatory Affairs, Quality Assurance, Relevant Process Development. /p h3Essential Skills, Knowledge and Attributes /h3 ul liIn‑depth understanding of GMP requirements in the pharmaceutical industry and previous Production, Quality or RD experience within the pharmaceutical industry /li liSound knowledge of processes for Clinical Trial GMP manufacture /li liUnderstanding of the product development process and environment is desirable /li liGood interpersonal, negotiation and influencing skills /li liAbility to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL /li liGood analytical and problem‑solving skills /liliAbility to work well independently and to self‑motivate /li liWell‑developed organisational and time management skills /li liPC skills (Microsoft Office) /li liStrong oral and written communication skills /li liTeam orientated /li liStrong customer focus /li /ul /p #J-18808-Ljbffr