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About the Role
PDP Consulting Ltd. is seeking a Documentation and IV Execution Lead to implement and support CQ related Documentation within the KNEAT Platform for ongoing client projects in the Biopharmaceutical/Pharmaceutical sector. This role is crucial for ensuring Technical and GDP Compliance with URS and Design Specifications.
Responsibilities
- 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 as Quality review and approver for executable test protocols (FAT, SAT, SU, OFT, IQ and OQ)
- Develop training matrix
- Organise training on relevant guidelines and procedures
- Manage overall training records for relevant Vendors and for the PDP CQ team
- 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
- Biweekly updates to CQ schedule including actualized and forecasting data for Doc Prep and Execution Phases
- Support development of the monthly project report including progress reporting, progress measurement, and scope changes
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
- Must be fluent in English
Skills
- CQV
- Project Management & Controls
- Operational Readiness
- KNEAT Platform
- URS
- TS
- FS Oversight
- CQ Plan Development
- EDRA Execution
- Gap Assessment
- DQs
- FAT
- SAT
- IV
- SU
- OFT
- IQ
- OQs
- Technical Compliance
- GDP Compliance
- Design Specifications
- VTOD
- CTOD
- CTPs
- Calibration Plan
- Master P+IDs
- ECNs
- Commissioning
- Validation
Location
- 151 Yonge Street, 11th Floor, Toronto, ON M5C 2W7
Work Type
- Full-time
- 40 hours per week
- Remote
Experience Level
- Minimum 10 years of experience
Education Level
- Bachelors degree in a related field
Salary/Compensations
- $230,000 – $260,000
About the Company
- Project Delivery Partners (PDP) is a specialized project delivery consulting company encompassing strong project management and technical expertise.
- Provides 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.