CSV and CQV Lead
Our client is a US MNC and a giant Pharmaceutical company. They are at the forefront of Medical Advances and Research.
*Please note that this is a 1-year contract position, with potential to renew.
- 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.
- 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, PQ), 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
- 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.
- At least ten (10) years combined experience across computer systems validation and equipment CQV, within a pharmaceutical environment, with increasing responsibilities culminating in a lead role.
- Comprehensive knowledge of regulatory and compliance requirements related to computerized systems and process equipment 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.
- Previous experience in a similar role for a brownfield environment. Experience in stakeholder management.
- 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
Interested candidates, please send in your application with your detailed and updated CV to Tammy Chew Wen Hui (R1877573) at firstname.lastname@example.org.
Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573