Overview
On Site
Full Time
Skills
Computer Science
Life Sciences
Computerized System Validation
Pharmaceutics
Medical Devices
GAMP
Enterprise Resource Planning
LIMS
MES
HP ALM
Manual Testing
Defect Management
Writing
Communication
Documentation
Organizational Skills
Cloud Computing
GxP
Data Integrity
Auditing
Job Details
Roles & Responsibilities:
- Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
- 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries.
- Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines.
- Experience with ERP, LIMS, MES, or other GxP systems.
- Extensive Experience in HPALM with Manual testing.
- Deep knowledge in Defect Management Life cycle.
- Proficient in writing validation protocols, reports, and SOPs.
- Strong communication, documentation, and organizational skills.
- Experience with cloud-based GxP systems.
- Familiarity with data integrity principles.
- Previous experience in audit preparation and support.
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