Document and IV execution lead

Project Delivery Partners

10d

About The Position

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.

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

• 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
• 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)
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees