Utilities Supervisor

2 weeks ago


Dubai, Dubai, United Arab Emirates Energy Jobline Full time
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 LevelPSCBiotech disrupts the conventional consultancy model by aligning ourEVP as one of the unique selling points which includes theopportunity to work with a highly talented cohort of like-mindedprofessionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment, providing exposure to working in TopPharmaceutical client sites in a diverse-cultural work setting. Employee ValuePropositionEmployees are the cornerstone of PSC Biotech. We offer unparalleledempowering career development through Learning & Developmentin-house training mentorship with constant guidance tofacilitate career progression. We aim to build highperforming teams that can surpass our clients' expectations in termsof quality of all scalable and business unit deliverables,staying under budget, and ensuring timely delivery of our projects.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 the interface of SAP with IPI Productstructure and MES BOMs and recipes. Otheractivities to support Quality Systems and QA Operations will berequired as per the start-up schedule.RequirementsWhatyou will do:Bring energy, knowledge, innovation, and leadership to carry out thefollowing:
  • LeadSAP master data build and data approval activities includinghypercare, sustainment materials build, BOMs, and Recipes.
  • Participatedaily on cross-functional teams collaboratively and actively toaddress compliance issues and achieve project milestones.
  • Supportimplementation and training for site Quality Systems and site GMPreadiness activities.
  • Supportcreation, maintenance, and continuous improvement of QualityManagement Systems (QMS) and associated documentation.
  • ProvideQA review and approval of Change Controls, Deviations/CAPAs, SOPS,and related documentation for compliance with GMP and siterequirements at the start-up facility.
  • Supportother QA colleagues, asrequired.
  • Workcollaboratively to foster strong relationships with management andcolleagues to drive a safe and compliant culture.
  • Supportgathering of sitemetrics.
  • Ensurethe escalation of risks to management in a timely manner.
Whatskills you willneed:To excel in this role, you will likely have:
  • 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 andmaintenance.
  • QMSdevelopment 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., orsimilar.
  • Strongwritten 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.

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