Role: Senior Quality Assurance
Location: Ireland Galway, Connacht
Type: Permanent, Hybrid
Required Skills and Experience:
· Minimum experience of 8 years and above in the above role and relevant to Pharma industry.
· Shall be able to communicate with business, site IT, CSV and GIDC team in English and local site language.
· Must have good knowledge of Regulations (i.e. 21 CFR Part 11, Annex 11, GMP), GAMP, CSV, QMS and documentation.
· Must have good knowledge of enterprise application used in Pharma industry, laboratory systems and manufacturing equipment automation with PLC/SCADA/IPCs.
· Must have worked on various aspects of CSV/QMS.
· Must have participated in regulatory inspections like USFDA, EU, WHO etc. & their compliance.
· Open-minded with positive error management approach.
· Responsible for review and approval of Computer system validation deliverables as per applicable IT QMS SOPs.
· Responsible for overall regulatory compliance of computerized systems used for GMP purposes.
· Responsible to review and approval of QMS activities e.g. Change Control, Incidents, investigation reports and CAPA’s related to Computerized systems.
· Responsible to conduct training in the areas of CSV and Data Integrity to facilitate validation activities.
· Responsible to support vendor assessment of IT system suppliers & compliance.
· Responsible for supporting regulatory inspections in the area of Computerized systems.
· Responsible to perform any other duties assigned by the reporting manager.
|Job Category||Senior Quality Assurance IT|