Data Integrity Specialist - in Engineering, Maintenance and Utilities (m/f)
(full time position based in Prigorje Brdovečko)
What you will do:
- Self-responsible implementation of Data Integrity Assessments in the working environment in EMU department
- Examine, visualize and optimize processes, equipment and software in relation to Data Integrity requirements
- Selection and procurement of new DI-compliant devices / software
- Close cooperation in the framework of Data Integrity investigations with the QA department
- Presentation of Qualifications and Data Integrity in audits and government inquiries
- Generate/Revise/Execute computerized system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, ULT, SLT, ILT, Validation Planning, FAT, SAT, IQ, OQ, PQ, Final Validation Summary Report
- Execute Commissioning, Installation, Operation and Performance Qualification Protocols for various automated life science equipment/platform (including IT platforms, manufacturing, facilities/utilities and packaging equipment)
- Conduct COTS software code review, software assessment to determine appropriate validation requirements.
- Support for DI-compliant SOP creation
- Check and formulate techniques for quality data collection to ensure adequacy, accuracy and legitimacy of data
- Devise and implement efficient and secure procedures for data handling and analysis with attention to all technical aspects
- Monitor and analyze information and data systems and evaluate their performance to discover ways of enhancing them (new technologies, upgrades etc.)
- Ensure digital databases and archives are protected from security breaches and data losses
- Troubleshoot data-related problems and authorize maintenance or modifications
- Acquire data from primary or secondary data sources and maintain databases/data systems
- Filter and “clean” data by reviewing computer reports, printouts, and performance indicators to locate and correct code problems
- Locate and define new process improvement opportunities
Required skills:
- University Degree or 300 ECTS – Electrotechnics or Mechanical Engineering in computor engineering field
- Proficiency in Croatian and English language
- IT (MS Office: Word, Excel, PowerPoint)
- Initial experience in the field of Data Integrity (DI), with Computer System Validation, (CSV) experience is an advantage
- Background in GxP/biopharma processing automation systems
- Sound knowledge of the operation and technique of equipment
- Experience in working in pharmaceutical industry in cGMP environment is an advantage
- Experience in project and quality management
- Profound knowledge of spoken and written English
- Strong background and understanding of current industry data integrity standards
- Understanding of quality systems such as change control and discrepancy investigations
- Candidates must have excellent verbal communication and technical writing skills
- Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
- Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents
- Ability to plan and manage own work
Candidate's profile:
- Accountable, adaptable, systematic and punctuate
- Interpersonal and communication skills
- Experience in team work
Please send your application and CV in English via link and search for JOB ID: 4881773. Selected applicants shall be contacted by e-mail or by phone for further selection process.
