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2479 Fusion Plus Solutions Jobs
CSV Subcon profiles required - 500096
2-4 years
Hyderabad / Secunderabad
1 vacancy
CSV Subcon profiles required - 500096
Fusion Plus Solutions
posted 4hr ago
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Key skills for the job
Job Description
- 6+ yrs. of Professional experience and strong knowledge with real time experiencein IT Quality Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
- Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQs, TRM.
- Assure compliance with GxP (GMP, GCP, GLP) privacy requirements. Develops and maintains IT GxP compliance documentation.
- Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
- Stakeholder management and good executor with required communication.
- Candidate must have fair conceptual understanding on below key areas
- IT QMS
- Validation/Qualification
- Risk management.
- Handling of defects/Deviations
- Investigations
- CAPA Handling
- Test Management Compliance
- Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
- Candidate will provide an application validation expertise practicallyon different scenarios as applicable case to case i.e., standalone/enterprise etc.
Employment Type: Full Time, Permanent
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