Ignacio Martin-Arjol

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Angestellt, Quality Assurance, INKE
Barcelona, Spain

Skills

Quality Management
Quality Control
Quality Assurance
Process Validation
Cleaning process validation
OOS
Deviations
LIMS
Validation
English Language
GMP
CAPA
QMS
Pharmacy
Laboratory
Analytics
CSV
Troubleshooting
Compliance
Pharmaceutical industry
Account Management
SME
Systems
Risk management
Biotechnology
Audit
Data Analysis
Risk Analysis
GxP
Natural Science
Scientific studies
FDA
Computer Science
CSA
German
Data Integrity
Team work
Communication skills
Flexibility
problem solving skills
Microbiology
SOP
Change Management
After Sales Support
KPI
API
IT Quality Management

Timeline

Professional experience for Ignacio Martin-Arjol

  • Current 2 years and 8 months, since Jan 2024

    Quality Assurance

    INKE

    - CSA and Data Integrity guidelines: software periodic review, GAMP 5 2nd CFR 21 Part 11 - Review of executed batch records of chemical processes, API production - PQR’s edition (statistical analysis, Minitab): quality KPI’s and stability analysis - Management of Deviations, OOS’s, OOT’s, CAPA’s - Assessment and Implementation of Change Controls and CAPA’s - Review and approval of SOPs, protocols, check-lists - CSV: URS, RA, IOQ, PQ, Trace Matrix, SOPs - Supporting internal audits

Languages

  • German

    A1-A2 (Basic)

  • English

    C1 (Fluent)

  • Spanish

    C2 (Expert / native speaker)

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