Overview
On Site
Full Time
Skills
Pharmaceutics
Management
Collaboration
Software Development
Computerized System Validation
IT Infrastructure
Backup
Microsoft Windows
Regulatory Compliance
Good Manufacturing Practice
GMP
Administrative Support
Job Details
Responsibilities:
- We are seeking a Validation & IT Systems Specialist to join our dynamic team.
- This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications.
- IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp.
- Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment.
- Manage system configurations, troubleshooting, and maintenance in collaboration with IT teams.
- Support the software development lifecycle, ensuring alignment with validation and compliance standards.
- Proven expertise in computer system validation (CSV) and GMP compliance.
- Overall 10+yrs of experience.
- Experienced in IT infrastructure CSV Qualifications (Authoring, Executing, and Reviewing the documents.
- Experienced in IT infrastructure administration functions (Server, Workstations, Backup, Controller, and Windows operating system).
- Validation Expertise - ensuring compliance with 21 CFR and Good Manufacturing Practice (GMP) standards.
- IT Administrative Support.
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