Position: DOCUMENTATION AND IV EXECUTION LEAD Company: PDP Consulting Ltd. Location: 151 Yonge Street, 11th Floor, Toronto, ON M5C 2W7Wages: Salary range $230,000 – $260,000 Position: Full time(40 hours per week) Vacancy: 1Project Delivery Partners (PDP) is a specialized project delivery consulting company encompassing strong project management and technical expertise; providing specialist services to the Biopharmaceutical/Pharmaceutical sector, focusing on CQV, Project Management & Controls and Operational Readiness.PDP’s core focus is fully understanding our client requirements and translating these needs into defined and approved project-scope statements that meet our clients’ organizational and business objectives. PDP has 3 key divisions in providing project delivery solutions that match our clients’ requirements and also work cross-functionality to provide the most cost-effective solution maximizing return on investment:Specialist Consulting DivisionProject Executive DecisionContingent Technical Services DivisionOur Toronto office is currently looking for a Documentation and IV Execution Lead for ongoing client projects. There is the option for remote work. 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, DQ’s and Preparation and Post Execution approval of CQ Docs (FAT, SAT, IV, SU, OFT, IQ’ and OQ’s) 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 LILLY Documentation Management TeamSupport with the development of the C&Q Plan & Kneat implementation PlanDevelopment of a Documentation Tracker for the PDP scopeManage 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 OQ’sDevelopment of Lilly CTP’s, IQ and OQ in line with approved URS, TS, FS, Calibration Plan and Master P+ID’sIV 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 ECN’sQuality 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 Handover Project Controls:(Support for PDP CQ Technical Lead)Biweekly updates to CQ schedule including ‘actualized’ and ‘forecasting’ data for Doc Prep and Execution PhasesSupport development of the monthly project report including but not limited to:Progress ReportingProgress measurementScope changesEmployment requirements Minimum 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 membersBachelor’s degree in a related field Must be fluent in EnglishTo apply please send your resume to [email protected]

📌 Documentation And Iv Execution Lead - $230,000 - $260,000 A Year (Mississauga)
🏢 PDP consulting
📍 Mississauga