Data Integrity & CSV Quality Expert
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Data Integrity & CSV Quality Expert
for the site Borgo San Michele LT Italy
Would you like to make a valuable contribution to the health of patients And do something really meaningful on your own responsibility Then we look forward to hearing from you! Excellence beyond manufacturing - thats what we stand for as Aenova one of the worlds leading contract manufacturers and developers for the pharmaceutical industry with 4000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production with a strategic investment plan to become one of Europes foremost hubs.
Your key responsibilities
- Lead and maintain the Site Data Integrity and CSV programs ensuring compliance with GxP and corporate standards (EU GMP Annex 11 21 CFR Part 11 ALCOA).
- Oversee the full Computer System Validation (CSV) lifecycle including planning testing documentation and periodic review.
- Define and monitor Data Integrity governance perform risk assessments and ensure compliant system implementation across Quality Manufacturing Engineering and Laboratory systems.
- Support deviation CAPA and change control management related to computerized systems and data integrity.
- Act as subject matter expert during audits and inspections providing training and promoting a strong data integrity culture.
Your profile
- Degree in Engineering Computer Science Chemistry Pharmaceutical Technology or related scientific field.
- Minimum 35 years of experience in Computer System Validation and Data Integrity within a pharmaceutical GMP environment.
- Deep knowledge of EU GMP Annex 11 FDA 21 CFR Part 11 ICH Q9 and Data Integrity guidelines (EMA MHRA FDA WHO).
- Strong understanding of IT systems used in GxP environments (e.g. SAP LIMS TrackWise SCADA EBR Empower).
- Excellent communication analytical and teamwork skills with very good English proficiency .
Please note:Applicationsmust be submitted in English. Applications in Italian or any other language willnot be considered.
Your motivation
Are you looking for new challenges in a highly competitive environment And you want to tackle them creatively and on your own responsibility Do you prefer a get-it-done culture and think in terms of solutions rather than problems What are you waiting for We would be happy to explain our corporate benefits in a personal conversation! If you have any questions I - Lukas Rödder / Human Resources - will be happy to help you: Haupt Pharma Latina S.r.l. Member of the Aenova Group Strada Statale 156 dei Monti Lepini 04100 Borgo San Michele LT Italy
Key Skills
- IDS
- System Design
- Haskell
- PCB
- Root cause Analysis
- Technical Writing
- System Security
- Federal Aviation Regulations
- Warehouse Distribution Experience
- Encryption
- Product Development
- Contracts
About Company
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