Utilities Supervisor
Detalhes do emprego
AboutPSC Biotech Who weare? PSCBiotech is a leading Biotech Consultancy firm founded in 1996,headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350clients in more than 23 countries worldwide. We provide cloud-basedsoftware solutions for Quality Management and RegulatoryInspections, pharmaceuticals contract manufacturing professionals,and metrology services to our clients. Takeyour Career to a new Level PSCBiotech disrupts the conventional consultancy model by aligning ourEVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-mindedprofessionals operating in the Pharma/ Biotech Industry. We offer apermanent contract of employment giving exposure of working in TopPharmaceutical client sites in a diverse-cultural worksetting. Employee ValuePropositionEmployees are the heartbeat of PSC Biotech, we provide unparalleledempowering career development though Learning & Developmentin-house training mentorship through constant guidance tofacilitate career progression. We believe in creating highperforming teams that can exceed our client s expectations withregards to quality of all scalable and business unit deliverables,staying under budget and ensuring timelines for our deliverablesare beingmet.Reportingto the Associate Director of Quality Assurance within GlobalDevelopment Quality (GDQ), the Quality Assurance role will supportthe wider Quality Assurance team at thesite. Thisrole will primarily provide support for SAP Quality Master Databuild, Master Data approvals hypercare, sustainment, and ongoingupdates. It will also support interface of SAP with IPI Productstructure and MES BOMs and recipes. Otheractivities to support Quality Systems and QA Operations will berequired as per start upschedule.RequirementsWhatyou will do: Bringenergy, knowledge, innovation and leadership to carry out thefollowing:LeadSAP master data build and data approval activities includinghypercare, sustainment materials build, BOMs andRecipes.Participatedaily on cross-functional teams collaboratively and actively toaddress compliance issues and achieve project milestones.Supportimplementation and training for site Quality Systems and site GMPreadinessactivities.Supportcreation, maintenance and continuous improvement of QualityManagement Systems (QMS) and associateddocumentation.ProvideQA review and approval of Change Controls, Deviations/CAPAs, SOPSand related documentation for compliance to GMP and siterequirements at the start-up facility.Supportother QA colleagues, asrequired.Workcollaboratively to foster strong relationships with management andcolleagues and to drive a safe and compliantculture.Supportgathering of sitemetricsEnsurethe escalation of risks to management in a timely manner.Whatskills you willneed:Inorder to excel in this role, you will more than likelyhave:5years experience in an FDA / EMA regulated environment, ideally inQuality Assurance, Quality Control, Operations or TechnicalOperations within the Biological and/or pharmaceutical industry.Previousexperience in SAP Master Data build andmaintenanceQMSdevelopment and maintenance.Previousexperience in Deviations and Change Control, participating ininvestigations and problemsolving.Strongattention to detail and precision in preparing and reviewing GMPdocumentation.Previousexperience in quality management systems such as Veeva,SAP, Delta-V, TrackWise, PAS-X etc. orsimilarStrongwritten and verbal communication skills.Ability tothink logically and be proactive under pressure.Ability towork as part of a team and on own initiative in a constructivemanner.Knowledgeof major Health Authority Guidelines and Regulations related toBiologics and/or Pharmaceuticals.Desirable:Experiencein direct interactions with regulatory agencies during siteinspection.#LI-AM1What you will do: Bring energy, knowledge, innovation andleadership to carry out the following: Lead SAP master data buildand data approval activities including hypercare, sustainmentmaterials build, BOMs and Recipes. Participate daily oncross-functional teams collaboratively and actively to addresscompliance issues and achieve project milestones. Supportimplementation and training for site Quality Systems and site GMPreadiness activities. Support creation, maintenance and continuousimprovement of Quality Management Systems (QMS) and associateddocumentation. Provide QA review and approval of Change Controls,Deviations/CAPAs, SOPS and related documentation for compliance toGMP and site requirements at the start-up facility. Support otherQA colleagues, as required. Work collaboratively to foster strongrelationships with management and colleagues and to drive a safeand compliant culture. Support gathering of site metrics Ensure theescalation of risks to management in a timely manner. What skillsyou will need: In order to excel in this role, you will more thanlikely have: 5 years experience in an FDA / EMA regulatedenvironment, ideally in Quality Assurance, Quality Control,Operations or Technical Operations within the Biological and/orpharmaceutical industry. Previous experience in SAP Master Databuild and maintenance QMS development and maintenance. Previousexperience in Deviations and Change Control, participating ininvestigations and problem solving. Strong attention to detail andprecision in preparing and reviewing GMP documentation. Previousexperience in quality management systems such as Veeva, SAP,Delta-V, TrackWise, PAS-X etc. or similar Strong written and verbalcommunication skills. Ability to think logically and be proactiveunder pressure. Ability to work as part of a team and on owninitiative in a constructive manner. Knowledge of major HealthAuthority Guidelines and Regulations related to Biologics and/orPharmaceuticals. Desirable: Experience in direct interactions withregulatory agencies during site inspection. INT
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