Upstream Compliance Coordinator

OverviewIndustry:Pharma/Biotech/Clinical ResearchLocation:Dublin, IrelandExperience:1-3 yearsJob DescriptionAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients."Take your Career to a new Level"PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry.We offer a permanent contract of employment giving exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting.Employee Value PropositionEmployees are the "heartbeat" of PSC Biotech.We provide unparalleled empowering career development through Learning & Development, in-house training, mentorship, and constant guidance to facilitate career progression.We aim to create high-performing teams that can exceed our client's expectations with regards to the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are met.Overview:A fantastic and exciting opportunity has arisen for an Upstream Operations Support Specialist.The role will provide key operational support to the Upstream shift teams to ensure right-first-time execution/delivery of manufacturing of batches.The Upstream Operations Support Specialist will support routine operations in the areas of safety and GMP compliance and will report to Upstream Operations Support Lead.This position will play a pivotal and critical role in the manufacture of biologics-based medicines, including immuno-oncology.ResponsibilitiesAs an Operations Specialist, you will work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations.This requires the delivery of process excellence and reliability across all areas of the IPT.Support Shift Operations team to consistently deliver on specific area KPIs, e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.Manage & track creation & updates to Standard Operating Procedures (SOPs) and Work Instructions (WI's) for New Product Introduction.Ownership of CAPAs.Support compliant operations through management of materials used in Upstream Operations.Data analysis supporting operations in safety, quality, delivery and cost.Link to finance department for monthly materials reporting and approvals.Liaise with stakeholders including Shift Operations, TechOps, Quality Assurance.Collate and analyse downtime tracking data and link to problem solving.Provide communication updates to manufacturing shift teams.Coordinate and support audits including preparatory work.Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs).Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.Coordination of Contractors and Visitors to BDS.QualificationsRequired Skills:Working knowledge of SAPExperience with Qualified Document Management systemsSelf-motivated with excellent organizational skillsAbility to interact with multiple stakeholders across numerous departmentsAbility to work independently and as part of a teamAdvanced soft skills (MS Word, Excel, PowerPoint) to generate metrics and presentations as applicableWorking knowledge of Upstream processes is highly desirableKnowledge of Lean Six Sigma and Lean methodologies, with an understanding of regulatory requirementsEducationDegree or 3rd level qualification (Science, Engineering)#J-*****-Ljbffr