What are the responsibilities and job description for the QC IT Application Analyst position at TekOne IT Services Pvt. Ltd.?
System Management: Manage IT projects such as system upgrades (e.g., from Windows 7 to Windows 10).
Vendor Coordination: Oversee vendor solutions and ensure compliance with technical requirements.
Technical Support: Respond to technical requests and collaborate with cross-functional teams (internal/external).
SDLC Documentation: Author and maintain Software Development Life Cycle (SDLC) documents, such as User Requirements Specifications (URS), Standard Operating Procedures (SOPs), and Installation/Operational Qualifications (IQ/OQ).
Compliance & Quality: Ensure GxP compliance, especially when working with lab equipment and systems.
Required Skills
IT/Business Experience: Minimum of 5 years in IT or business roles, preferably in the Pharmaceuticals or Life Sciences sector.
CSV and GxP Compliance: Strong experience with Computer System Validation (CSV) and knowledge of 21 CFR Part 11 regulations.
Tools & Technologies:
Familiarity with ServiceNow, Veeva, and TrackWise.
Experience with automation systems like SCADA, PLCs, and BAS.
Knowledge of analytical instruments such as Empower and Chromeleon.
IT Tools: Proficient with Microsoft Office 365, Visio, Project, SQL, Active Directory, and Citrix.
ITIL Processes: Experience with Incident, Change, and Asset Management.
Education
Bachelor's Degree in IT, Computer Science, Engineering, or a related field.
Physical Requirements
Must be able to lift/carry up to 30 lbs.
Must be able to work in controlled environments with strict gowning protocols.
Overtime work may be required as needed.
Onsite Expectations
Onboarding and Training: 4-5 days onsite per week for the first few weeks.
Post-Onboarding: 3 days onsite per week, with flexibility for occasional 4-5 day onsite requirements.
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