- Promote and demonstrate a safety and compliance focused mindset within the project environment.
- 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 with requirements.
- 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
- At least ten (10) years combined experience across computer systems, equipment and process qualification, within a pharmaceutical environment
- Comprehensive knowledge of regulatory and compliance requirements related to process validation in an FDA-regulated environment.
- Thorough understanding of computer systems validation, SDLC methodologies and testing best practices.
- Extensive knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
- Must be able to demonstrate an ability to develop strategies for successful project delivery
- Previous experience in a similar role for a brownfield environment.
- Project management experience in cost control, resource allocation, schedule and risk management
- Working knowledge (non-SME) of DeltaV process control systems such as architecture, design, implementation, integration or support.
- Experience (non-SME) of Yokogawa Centum PCS, safety instrumented systems and vendor plc package interfaces a plus
Keywords: Validation, Qualification, CSV, CQV, Automation, Lead, Project, Pharmaceutical, Biotech
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017