Document and IV execution lead

Documentation and IV execution lead – US opportunityAbout US :EFOR is an ambitious consultancy with over 3,000 consultants, specializing in the life sciences sector.About the Role:The Documentation and IV Execution Lead is responsible for implementing and supporting CQ related Documentation, including but not limited to URS, TS, FS Oversight, Development of CQ Plan, Execution of EDRA,Gap Assessment, DQs and Preparation and Post Execution approval of CQ Docs (FAT, SAT, IV, SU, OFT, IQ and OQs) within the KNEAT Platform In line with PDP and Client C+Q requirements, the KNEAT Documentation Lead shall adhere to the Baseline Schedule and ensure Technical and GDP Compliance with URS and Design Specifications.Responsibilities relating to CQ documentation include:Meeting and delivering key project milestonesActively manage lifecycle CQ Documentation within the Kneat platformCoordinating development and approvals with the Client and with other disciplines including Vendors, Automation, E+I, and USER in line with WorkflowDeveloping positive working relationship with team members and USER groupsEnsuring adherence to schedule, review cycle and quality (Function and GDP content)Liaise closely with the Kneat Implementation SMELiaise closely with Documentation Management TeamSupport with the development of the C&Q Plan & Kneat implementation PlanDevelopment of a Documentation TrackerManage review and approval of VTOD and CTODActively manage CQ Documentation Preparation teamURS ReviewsEDRA, GAP Analysis, DQ ExecutionReview of Vendor Docs incl FAT and SAT, SU, OFT, IQ and OQsDevelopment of CTPs, IQ and OQ in line with approved URS, TS, FS, Calibration Plan and Master P+IDsIV Readiness and IV Execution LeadershipAct a Quality review and approver for executable test protocols (FAT, SAT, SU, OFT, IQ and OQ)TrainingDevelop training matrixOrganise training on relevant guidelines and proceduresManage overall training records for relevant Vendors and for the PDP CQ teamCQ Execution SupportAttendance at daily multidisciplinary CQV, Eng, CM and USER coordination meetings are establishedSupport CQ execution team with documentation updates:Review and Approval Of CTOP and VTOPExecution of IV + IQChasing vendor and or construction documents to support IV + IQActively manage Incidents + DeviationsSupport ECNsQuality review and approval of executed test protocols (FAT, SAT,SU, OFT IQ and OQ)Tracking of changes, punch items and deficienciesEnsuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, VTOD, CTOD and SAT)Actively support System HandoverProject Controls: (Support for CQ Technical Lead)Biweekly updates to CQ schedule including actualized and forecasting data for Doc Prep and Execution PhasesEmployment requirementsMinimum 10 years of experience in Quality Assurance (QA), Qualification and ValidationStrong knowledge and experience of detailed Installation Verification, Commissioning, Qualification and Validation in Pharmaceutical ManufacturingAbility to lead a team and train new team membersBachelors degree in a related fieldMust be fluent in English