CSV Analyst
Pharmathen
- Μαρούσι, Αττικής
- Μόνιμη
- Πλήρης Απασχόληση
- Participate at the generation & execution of various GMP related documents and protocols, including URS, FS/DS, IQ, OQ & PQ
- Participate at the creation, revision and implementation of IT related policies or procedures.
- Assist in the audit, review, development and implementation of computerized systems to assure they meet required standards of quality and compliance
- Assist in queries regarding computer systems operation, development and validation during regulatory and due diligence inspections
- Collaborate with other departments to monitor compliance to standards/regulations that dictate the operation of the company’s IT systems
- Communicate with external parties (customers, suppliers) to ensure an appropriate level of support.
- Manage and support the core project team/users on a day-to-day basis
- Configure, and control operating systems, software applications, for ensuring the data integrity of GxP critical data.
- Assist in managing user accounts, permissions, and access rights across various systems and applications
- BSc in Electrical Engineering, Computer Science or relevant field
- Minimum of 4 years experience in a similar role
- Basic knowledge of Computerized Systems Validation – Legislation
- Proficient with MS word and other computer skills
- In depth knowledge of preparation of Validation/Verification Protocols (URS, FS, DS documents)
- In depth knowledge of preparation-execution of automated/manual testing scripts (IQ/OQ/PQ Documents)
- Participation on SAT (Site Acceptance Test)/ UAT (User Acceptance Test) Activities
- Good Documentation Practices
- Strong understanding of Risk Management Methodology for Validation
- IT-QA Audits for leveraging of software supplier
- Experience in Deviation Investigation
- Change Control Management
- Excellent communication in English language (writing & speaking)
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills