Document and IV execution lead

Project Delivery Partners Pte Ltd; Massachusetts; On-site; USD 120,000 - 150,000; Full time

Job summary

A consultancy in life sciences is seeking a Document and IV Execution Lead to enhance CQ documentation processes. The successful candidate will implement and manage critical documentation using the Kneat platform. Responsibilities include leading a team, adhering to project milestones, and ensuring compliance with pharmaceutical regulations. Strong experience in Quality Assurance and team training is essential. English fluency and a Bachelor's degree in a related field are required.

Qualifications

• Minimum 10 years of experience in Quality Assurance (QA), Qualification and Validation.
• Strong knowledge of Installation Verification, Commissioning, and Validation.

Responsibilities

• Implement and support CQ related Documentation.
• Manage lifecycle CQ Documentation within the Kneat platform.
• Support recruitment and training of new team members.

Skills

Quality Assurance (QA)

Qualification and Validation

Team Leadership

Pharmaceutical Manufacturing

English fluency

Education

Bachelor's degree in a related field

Job description

Document and IV execution lead

Job Description:

Documentation and IV execution lead– US opportunity

About US :

EFOR is an ambitious consultancy with over 3,000 consultants, specializing in the life sciences sector.

About the Role:

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
• 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 CQ Technical Lead)

Biweekly updates to CQ schedule including actualized and forecasting data for Doc Prep and Execution Phases

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