Montash have been engaged by a Global Pharmaceutical Client to source a Support Consultant to join the QA/CVS Manager on a global project
You will support the regional "Hub WA/CSV Manager" to ensure that the processes within computerised systems are implemented and used in a compliant manner following all external and internal regulations.
- Approval of System Life Cycle documentation in compliance to the respective validation methodology
- Support deployment according to the Quality Gate deliverables (e. g. Fit to Standard Workshops, training, etc.)
- Ensure audit readiness and supports regional audits of systems in scope of the position
- Regional interactions with all relevant business units (i.e. Production sites and commercial sites) and Global Functions, as well as cross functional project teams
- Support the handover of quality tasks to the run organization
- Support that further externals which supporting other internal department(s) are working under the agreed methodology.
- Guides and defines work packages for external support and monitors the quality of deliverables.
- Support the identification of local Key Users (e. g. for ERP (SAP), Trackwise) related to quality processes tasks
- Partner with and educate business stakeholders and cross functional project teams through coaching and education regarding the need for compliance with regulations and quality management processes.
- Manage existing/additional SOPs where applicable
- Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise (minimum of 5 years)
- Profound knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems -
including external regulations e.g. EU-GMP Guideline, Annex 11, 21 CFR Part 11, Data Integrity requirements and internal regulations (LeVA)
- Speak-up mentality/ ability to challenge and make judgment calls with Senior Management
- Ability to manage externals and work in a matrix organization
- Risk Management capabilities (joint risk mapping, risk assessment, risk acceptance and risk communication)
- Ability to prioritize and to effectively manage multiple tasks at the same time, quickly respond to changing internal and external requirements
- Respect and understanding of cultural diversities across the area of responsibility
- Live BI's behavioral framework of Accountability-Agility-Intrapreneurship
- Collaborative and integrated working style, act as solution contributor with proactive quality involvement
- Fluent in English (writing and verbal), preferable one additional regional key language, e.g. Spanish for Central and South America, Mandarin for China/ Asia
- Preparedness to travel
qa / cvs / sap / sdlc / system lifecycle / cGMP / GAM5 / uat test / sap ecc / annex