Luke Black
- Role
- Validation & Quality Manager, Pharma Supply Chain - Global Computer Validation (Psc Gcv) at GSK
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Luke Black
Executive Summary:* 25 years of GMP experience in the Pharmaceutical Industry;*…
Experience
Validation & Quality Manager, Pharma Supply Chain - Global Computer Validation (Psc Gcv)
Jan 2019 — Present
Current GCV Secondment role at GSK Role & Responsibilities: • Providing Quality oversight to support implementation and maintenance of strategic computerized systems requiring validation, including but not limited to automation of business processes associated with pharmaceutical manufacture, laboratory and distribution. • Project problem identification / resolution / avoidance, typically involving ongoing interaction with management teams within IT functions, site and local operating company Quality organizations, and Third-Party suppliers/service providers. • Managing deployment, maintenance and inspection support of global projects, identifying solutions to maintain compliance and ensure on time scheduling and budget for validation projects. Fulfilling the Quality Assurance role in accordance with relevant procedures for the preparation and approval of validation documentation and/or management of the process. Planning and managing validation of high cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose. • Ensuring issues and risks are identified, mitigated and/or escalated for items that could adversely impact quality and compliance associated with projects/systems, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes. • Development, management and reporting of performance measures to drive performance and continuous improvement. • Managing contingent workers assigned to project activities including budgeting and forecasting of project costs. • Providing consulting and inspection support to the user community.
Skills
- Good Laboratory Practice (Glp)
- Gmp
- Pharmaceutical Industry
- Standard Operating Procedure (Sop)
- Quality Assurance
- U.s. Food and Drug Administration (Fda)
- Validation
- 21 Cfr Part 11
- Change Control
- Gxp
- Sop
- Gcp
- Computer System Validation
- Project Management
- Glp
- Internal Audit
- Fda
- Manufacturing
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