Promote and demonstrate a safety and compliance focused mindset within the project environment.
Play an integral role in ensuring that GxP computerized systems, associate infrastructure and process / utilities equipment are commissioned, qualified and validated in accordance with corporate quality
standards and regulatory requirements.
Develop qualification and validation strategies to deliver project goals to quality requirements on time and within budget
Lead effort to develop / review / approve all project execution / SDLC document deliverables including, but not limited to Plans (QAP, Test, Migration, Execution), Specifications (Design, Configuration, Functional,
Requirements), Assessments (Risk, Gap), Reviews (design, code), Test Protocols (FAT, SAT, UAT, IQ, OQ,PPQ), Traceability Matrices and Reports (validation summary, progress)
Interface with internal and external partners to identify existing or potential issues and work collaboratively to develop solutions.
Manages team / coordinates testing, qualification and validation project activities through all phases of the project. Develops work plans, schedules, strategies and plans for CSV / CQV activities in alignment
Lead and coordinates effort to develop engineering / GMP change controls to cover the scope of migration project.
Ensures all SDLC deliverables are developed based on standard templates and approved as per requirements whilst meeting business, technical and regulatory requirements
Support development of overall project schedule and provide input through full lifecycle providing regular updates and progress reports.
Provide SME guidance to end users and vendor across all project phases
Work with users & vendors on the computerised system solution providing input from a CSV perspective
Work with stakeholders to resolve or escalates issues to program manager in a timely manner
Leads regulatory focused risk assessments / FMEAs and workshops
Ensures project team members and vendors receive cGMP, Safety and role-related training required to work safely and in compliance with regulatory requirements
Participate in effort to ensure knowledge transfer to end users and support teams
Prepares & facilitates CSV / CQV team coordination meetings.
Demonstrates ability to work independently and able to define the scope and boundary of relevant activities.
Effectively analyse, frame and present information in a clear and unambiguous manner to all stakeholders.
Execute other tasks as may be assigned by the program manager