DOCUMENTATION AND IV EXECUTION LEAD

Company: PDP Consulting Ltd.

Location: 151 Yonge Street, 11th Floor, Toronto, ON M5C 2W7

Wages: Salary range $230,000 – $260,000

Position: Full-time(40 hours per week)

Vacancy: 1

Project 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.

PDPs 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 Division
• Project Executive Decision
• Contingent Technical Services Division

Our 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, 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 milestones
• Actively manage 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 relationship with team members and USER groups
• Ensuring adherence to schedule, review cycle and quality (Function and GDP content)
• Liaise closely with the Kneat Implementation SME
• Liaise closely with Documentation Management Team
• Support with the development of the C&Q Plan & Kneat implementation Plan
• Development of a Documentation Tracker for the PDP scope
• Manage review and approval of VTOD and CTOD
• Actively manage 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
• Act a Quality review and approver for executable test protocols (FAT, SAT, SU, OFT, IQ and OQ)
• Training
  • Develop training matrix
  • Organise training on relevant guidelines and procedures
  • Manage overall training records for relevant Vendors and for the PDP CQ team

CQ Execution Support

• Attendance at daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established
• Support 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 manage Incidents + Deviations
  • Support 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 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 Phases
• Support development of the monthly project report including but not limited to:
  • Progress Reporting
  • Progress measurement
  • Scope changes

Employment 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

To apply please send your resume to [email protected]