DOCUMENTATION AND IV EXECUTION LEAD

Project Delivery Partners • Toronto, ON

33d • CA$230,000 - CA$260,000 • Hybrid

About The Position

Project Delivery Partners (PDP) is a specialized project delivery consulting company with strong project management and technical expertise, providing specialist services to the Biopharmaceutical/Pharmaceutical sector. PDP focuses on CQV, Project Management & Controls, and Operational Readiness. The company's core focus is fully understanding client requirements and translating these needs into defined and approved project-scope statements that meet organizational and business objectives. PDP has 3 key divisions: Specialist Consulting Division, Project Executive Decision, and Contingent Technical Services Division. Our Toronto office is currently looking for a Documentation and IV Execution Lead for ongoing client projects, with the option for remote work.

Requirements

• Minimum 10 years of experience in Quality Assurance (QA), Qualification and Validation.
• Strong knowledge and experience of detailed Installation Verification, Commissioning, Qualification and Validation in Pharmaceutical Manufacturing.
• Ability to lead a team and train new team members.
• Bachelors degree in a related field.
• Must be fluent in English.

Responsibilities

• 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.
• Adhering to the Baseline Schedule and ensuring Technical and GDP Compliance with URS and Design Specifications.
• Meeting and delivering key project milestones.
• Actively managing lifecycle CQ Documentation within the Kneat platform.
• Coordinating development and approvals with the Client and with other disciplines including Vendors, Automation, E+I, and USER in line with Workflow.
• Developing positive working relationships with team members and USER groups.
• Ensuring adherence to schedule, review cycle, and quality (Function and GDP content).
• Liaising closely with the Kneat Implementation SME.
• Liaising closely with the Documentation Management Team.
• Supporting the development of the C&Q Plan & Kneat implementation Plan.
• Developing a Documentation Tracker for the PDP scope.
• Managing review and approval of VTOD and CTOD.
• Actively managing the CQ Documentation Preparation team.
• URS Reviews.
• EDRA, GAP Analysis, DQ Execution.
• Review of Vendor Docs incl FAT and SAT, SU, OFT, IQ and OQs.
• Development of CTPs, IQ and OQ in line with approved URS, TS, FS, Calibration Plan and Master P+IDs.
• IV Readiness and IV Execution Leadership.
• Acting as a Quality reviewer and approver for executable test protocols (FAT, SAT, SU, OFT, IQ and OQ).
• Developing a training matrix.
• Organizing training on relevant guidelines and procedures.
• Managing overall training records for relevant Vendors and for the PDP CQ team.
• Attending daily multidisciplinary CQV, Eng, CM and USER coordination meetings.
• Supporting the CQ execution team with documentation updates.
• Review and Approval Of CTOP and VTOP.
• Execution of IV + IQ.
• Chasing vendor and/or construction documents to support IV + IQ.
• Actively managing Incidents + Deviations.
• Supporting ECNs.
• Quality review and approval of executed test protocols (FAT, SAT, SU, OFT IQ and OQ).
• Tracking of changes, punch items, and deficiencies.
• Ensuring compliance of commissioning activities with qualification requirements where test results are subject to leveraging (FAT, VTOD, CTOD and SAT).
• Actively supporting System Handover.
• Providing bi-weekly updates to the CQ schedule including actualized and forecasting data for Doc Prep and Execution Phases.
• Supporting the development of the monthly project report including Progress Reporting, Progress measurement, Scope changes.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior