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QA Project Lead – Cell Therapy Expansion Project
The QA Project Lead will be responsible for managing Project Quality Assurance activities for our client’s West Dublin based State of the Art Cell Therapy Facility. This is an €40 Million expansion project and will be the largest C&G facility of its kind in Europe. The QA Project Lead will join the Senior Project Management team and be a major contributor to the success of this project. This is a long term contract opportunity for up to 2 years and offers highly competitive rates.
The QA Project Lead will be an experienced project focused quality professional, with highly developed management and communications skills. The successful applicant will be commercially minded, possess sound business acumen and have a proven track record of achievement in recent biopharma, aseptic process start up project environments.
Ideally they will be aware of latest developments in pharmaceutical technology and recognises the particular economic and technological significance of Cell & Gene Therapy product manufacturing within the Irish and International Pharmaceutical manufacturing industries.
The successful applicant will have a strong and outgoing personality, capable of expressing and supporting their business viewpoints and opinions based on professional and technical experience, knowledge and interpretation of company and international Quality Assurance codes standards and specifications in achieving project milestones and outcomes.
Senior Project QA representative during Facility Construction
Provide Project Quality oversight and approval of Construction and CQV activities
Quality signatory for final review & approval of validation & project documentation associated with facility, utility, equipment & systems qualification for start-up facility.
Drive implementation and execution of Construction Project Quality Assurance Systems
Validation SME for inspections, audits, deviations, and investigations
Review Project Change Control, Deviation Management, Process Validation, Cleaning Validation.
Quality Lead for Qualification of various Processes within the facility.
Develop, monitor & act on key performance indicators for quality.
Mentor & coach junior Quality associates on correct quality approach & requirements in meeting regulatory guidelines.
Provide Quality Assurance overview of notifications to include complaints, deviations, change requests, change controls, Rik management and Corrective Preventive actions.
Facilitate cross functional meetings to determine defect classification and level of investigation required.
Recommend Process / system changes based on investigations, root cause analyses and trend analyses.
Ensure closure timelines for all notifications -complaints, deviations, change requests and change controls.
Review and approval of all CQV Documentation required for initiation of Process Validation Campaigns.
Responsible for continuous improvement on site, improving site KPI’s, meeting all Project Milestone / targets on time.
Approve and compile validation protocols and reports (analytical, cleaning, computer, process, equipment, etc)
Update and approve site documentation as necessary.
Compile Site Master File, Quality reports as required.
Procedural Review and update of SOPs as necessary
Project QA assessor monitoring, addressing and closing out CAPAs, Deviations and change controls.
Project Quality representative – design issues / quality approver of finishes, process systems, utilities/ equipment.
QA Support for C&Q activities for new Equipment, Cleanrooms, Utilities and Automation.
QA support for Cleaning Validations.
Lead GMP and Facility Design Reviews.
Review, Approval and Coordination of GMP Change Controls, Deviations, Process Technology Transfer Documentation and Operational Documentation (SOPs, Work instructions, etc.)
Participation in Regulatory Inspections.
Compilation and Implementation of all policies required for new Takeda GC facility including:
o Document Management Strategy
o Vendor Qualification
o Risk Management
o Internal Audit programme
o GMP Training.
Project Lead for corporate, IMB and FDA regulatory inspections.
QA Budget compilation and management.
Leadership focused on achieving key project milestones including commissioning, qualification and validation of process systems including associated equipment and utilities.
Masters in Engineering, Quality Management.
10- 15 years Track record of successful start-up fast track pharma construction project environments
Capital Build Pharmaceutical / Life Science Project experience
Knowledge and experience of working on build of Aseptic Process Manufacturing facilities.
Good To Have
Cell & Gene Therapy Projects Experience
Project Management qualification
+7 years’ experience working an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
Minimum of 3 years’ experience in a people management role
Primary Degree in Scientific discipline
Qualified Person status is highly desirable but not essential