IT Project Manager
My client, a leading Pharmaceutical company are currently recruiting for an experienced Project Manager with prior experience in a Global Bio-Pharmaceutical or equivalent type industry.
The successful candidate will be a proven Project Manager with prior experience of working in a Global Pharmaceutical organisation, leading cross functional teams and has prior experience of working with MES
BSc. Degree (Technology related preferred) with 5+ years' experience working as a Project Manager in a Global Bio-Pharmaceutical or equivalent type industry.
5+ years technology or information systems experience
Project Management Certification in PMP, Prince 2 or equivalent preferred.
Experience/Knowledge in ERP, LIMS, EDMS, QMS, MES (PAS-X).
Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Powerpoint).
Strong knowledge of business processes across manufacturing, supply chain & quality
Experience with Computer Systems Validation preferred
Knowledge of 21 CFR Part 11 and EU Annex 11 regulations preferred
Independent problems solving skills
Experience implementing business improvements through more effective use of Enterprise Applications and related software
Very strong interpersonal and communication skills.
Yellow/Green Belt in Lean Six Sigma
Demonstrated experience in leading projects from Design to Qualification.
Good verbal and written communication skills.
Good organisational skills.
Must have good interpersonal skills. Position will involve a lot of interdepartmental interaction and coordination.
Must possess a thorough understanding of GxP, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.
Must possess a thorough understanding of current industry guidance, including GAMP 5
Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
Single point of contact from the IM (Innovative Medicines) team on the MES Program.
Coordinate IT related activities throughout the project life cycle to ensure that projects goals, budget and schedules are met.
Manage spend, forecasting to financial close-out ensuring a continual focus on cost awareness.
Work with project sponsor and stakeholders to manage scope, goals, deliverable, resource management, risks and issue management, budget and timeline.
Ensure that IM scope is delivered to meet customer expectations and in line with IM standards
Monitor progress of project milestones with all team members and provide status reports. Ensure that adequate communication plans are in place and delivered to ensure that all project stakeholders are informed and consulted on key project activities, progress and decisions.
Develop and maintain appropriate electronic and paper documentation & filing systems to ensure that all project documents are filed during project execution and safely archived following project completion.
Ensures that good Project management practices are utilised and aligned with customer's needs from requirements gathering, through design and execution.
Manage project changes and ensure all are captured, documented and assessed.
Generate IT change controls and drive their closure in a timely manner
Responsibility for direct supervision of vendor engineers and contractors as required.
Uses knowledge and expertise to challenge/question and coach/mentor others to do the same.
Considers global/site implications for decisions made and actions taken.
Promotes a safety and quality compliant culture across site.
Uses cost-benefit thinking to set priorities.
Analyses tasks to identify efficiencies and ensure efforts are focused on business critical and business improvement activities.