Gemma Ash
Director of Quality Assurance @Seda Pharmaceutical Development & Clinical Manufacturing Services
Signup · Get unlimited contacts
WORK HISTORY
Director of Quality Assurance @Seda Pharmaceutical Development & Clinical Manufacturing Services
EDUCATION
The Manchester Metropolitan University
Bachelor's degree, Chemistry
SKILLS
ABOUT GEMMA ASH
Experienced People and Project managerPrevious RolesQA Manager: Quality Assurance Manager, responsible for Quality Systems, Customer Complaints, Production Support, RCA, Site Compliance, Supplier Assurance and Internal Audits. Qualified IRCA lead auditor. Regulatory and third party audit host.Head of QA: Responsible for Site compliance, Quality Systems, Customer Complaints, Pharmacy, Production Support and Process Improvements and Internal Audits. Quality Systems Leader, responsible for Deviations, CAPA, Change Control, Supplier Assurance, electronic management Systems and incoming goods support. Analytical Transfer Leader: Project Manager of the Transfer of analytical test methods to an EU laboratory, in preperation for a hard brexit.Analytical Specialist: Key Customer contact. Responsible for Investigation, Method development and transfer, Continuous Improvement within Quality ControlExperienced in statistical analysis and interpretation utilising JMP software.Good cGMP and cGLP knowledge. Empower and LIMS superuser.Experienced in the following Lean tools:5sValue stream mappingKanBansGemba8DPPSMedical Device Industrialisation:Writing, Execution and Approval of investigational protocols/technical reports/quality risk assessments and SOPsISO 20072 ISO 14971Essential RequirementsMedicinal ProductsLeading Device Development and Verification Programmes and all associated investigations.Experienced with Tablets, Liquids, Injectables, Raw materials, pMDI and DPI formulations
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.