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$230k–$260k/yr
Full-time
bachelor degree
Posted 10d ago
~40 hrs/week
Remote in Toronto, Ontario, Canada
Responsibilities
The Documentation and IV Execution Lead is responsible for managing the lifecycle of CQ documentation within the Kneat platform and ensuring technical and GDP compliance. They will lead IV execution, coordinate with multidisciplinary teams, and support project controls through progress reporting and schedule management.
Requirements
Candidates must have a minimum of 10 years of experience in Quality Assurance, Qualification, and Validation within the pharmaceutical manufacturing sector. A bachelor's degree in a related field and fluency in English are required for this role.
Full job description
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
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
41,967
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN