Description
Solution Architect with Accelrys Discoverant experience required by Whitehall Resources for a four month contract based in Manchester.
Job Roles/Responsibilities
1.Study the existing landscape in the Manufacturing site to understand the Current Processes Performance, Process validation, Product Quality Monitoring, Process data collection/aggregation/reporting, Data Access levels, Process monitoring aspects, etc
2.Design High Level Solution for a well defined system for Process Performance and Product Quality Monitoring as part of client's CPV (Continuous Process Verification) initiative which is a FDA/EMA regulatory requirement. The solution should provide quick access to data and statistical process control for the site with production run rate of 5 day run-rate initiative.
3.Hold meetings with Client stakeholders for requirement gathering, system study, solution presentation, etc
4.Status reporting to both Client management
5.Project management - Ensure project meets the Quality/Schedule and Budget limits.
Required Skills/Experience:
- Manufacturing domain knowledge
- Manufacturing Intelligence related systems/applications/experience
- Must have - functional knowledge of Accelrys Discoverant (A-k-a) Aegis Discoverant).
- Good understanding and exposure to PMI (Process Management Informatics)
- Experience with Process Improvements, Validations aspects
- Quality and Regulatory Compliance requirements in Manufacturing/Pharma Industry (21 CFR Part 11, GxP, GMP, USFDA)
- Experience in Solution Designing and Presenting
- Understanding and experience on SPC - Statistical Process Control
Desirable Experience/Skills:
- Pharmaceutical Industry exposure
- Project Management
- Client Interaction
- SQC
- Statistical Quality Control