About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud -based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients. 'Take your Career to a new Level'PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like -minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse -cultural work setting. Employee Value PropositionEmployees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin -house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met. Overview:An amazing opportunity has arisen for a QA Specialist QMS(Quality Management Systems)This role will be responsible for supporting the QualityDepartment. Ensure that objectives are effectively achieved, consistent withthe company requirements to ensure compliance, safety and reliable supply toour customers.
RequirementsSkills, Responsibilities & Qualification:Internal and external inspection and auditing, changecontrol management, quality systems management, GMP training & knowledgemanagement.Supporting the management of the site Documentation / SOPmanagement systemsProvides compliance contribution to project teams andleads specific projects.Understands and applies regulatory / compliancerequirements to their role together with remaining current on upcomingregulatory and compliance changes.Responds to non -standard requests from customer needs.Makes decisions within guidelines and policies whichimpact own priorities and allocation of time to meet deadlines.Use standard systems including MS Word, Excel,PowerPoint, Outlook, SAP and various company and industry specific softwaresuch as document tracking, work order entry/tracking, procurement,manufacturing entry/reporting, etc.Presentation, compilation and review of data as directedProvide quality support to the site, including trainingand guidance on the interpretation and implementation of Our Company'sGuidelines / Policies and regulatory requirements.Bachelor's degree (or higher) in Chemistry, Biology,Microbiology, Automation, Engineering or equivalentA minimum of 3 -4years experience in Quality Control, Quality Assurance or Pharmaceutical orBiological OperationsKnowledge of EU/US quality related pharmaceuticalregulationsBasic computer literacyStrong communication skillsHigh level of technical aptitude & motivationDemonstrated initiative and pays attention to detailGood presentation skills.Excellent knowledge of relevant Quality and GMPCompliance Guidelines