About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, 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 point 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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Job Title: Quality Assurance SpecialistJob Description & Specific Objectives:The Quality Assurance Specialist is required to:· Work a 4-shift pattern role.· Technical knowledge of sterile manufacturing processes· Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk.· Respond quickly to unplanned events, technical issues.· Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES· Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements· Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.· Support the spot check/walk-through process of the production lines.· Involved in customer complaint investigation if required.· Support the annual product quality reviews if required.RequirementsPosition Responsibilities:· Provide Quality support to IPT production teams to ensure cGMP standards are maintained.· Understanding of sterile manufacturing operations is preferred.· Ability to learn and utilize computerized systems for daily performance of tasks.· Ability to prioritize, manage multiple tasks, and meet deadlines.· Perform timely reviews on batch documentation (EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards· Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.· Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.· Foster a culture of continuous improvement by deploying client Six Sigma tools and support implementation of Model Area within operations from the start.Reporting Structure: Quality Assurance IPT ManagerQualifications & Experience - Knowledge and Skills Requirements:Technical:· Sterile filling processes and equipment and support services experience· Lean Six Sigma Methodology experience desired.Education:· Degree qualification or equivalent (Science, Engineering, Technical)· Experience in Sterile ManufacturingGeneral:· Good organizational skills and attention to detail· Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.· Ability to learn and utilize computerized systems for daily performance of tasks.· Strong influencing skills· Demonstrable analytical and systematic problem-solving skillsPeople:· Focus on Customers and Patients· Collaborate· Act with Candour and Courage· Make Rapid, Disciplined Decisions· Drive Results· Demonstrate Ethics and Integrity#LI-KV2
