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Hi,
I am Rakesh from Anveta. I am trying to reach you for Job opportunity for CSA Validation Engineer at Eli Lilly, Indianapolis (Onsite).
Please share me below detail for quick submission along with resume.
Work authorization:
Current location::
Local DL:
LinkedIn Id:
Computer Software Assurance Validation Engineer
Eli Lilly, Indianapolis
- Expert in CSA validation principles.
- Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process.
- Developing, reviewing, and executing testing documentation.
- Direct experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
- Hands on experience with lab techniques and general lab analytical operations.
- Understanding of baselined lab standards and system suitability verification.
- Basic experience with IT system formats, configurations, and workflows.
- General understanding of the business processes supporting one or more domains, such as: Clinical, Quality System Management, Commercialization.
- Create and revision of all IT CSV project and system deliverables including but not limited to:
- Plans
- Requirements
- Specifications
- Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.
- Summary Reports
- Change Controls
- Review system operational and administration procedures to ensure they are adequate
- Document any findings of non-compliance
- Assist with strategy regarding remediation activities
- Assist with review of remediation activities
- Must be willing to work onsite in Indianapolis, IN
- Strong understanding of CSA principles and how to leverage them in a lab validation setting.
- Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor.
- Act as the Subject Matter Expert on various pieces of lab equipment
- Demonstrated experience in leading lab CSV activities specific to Process Equipment
- Ability to work as part of a team.
- Experience in GMP regulated environment.
- Proven attention to detail and organization in project work.
- Capable of working on assigned tasks without mentorship.
- Demonstrated ability to generate CSV deliverables independently.
Thanks & Regards,
Email is the best way to reach Me!!!
Rakesh Jaiswal
Technical Recruiter
Direct: 4694980074
Anveta Inc.
Email: [email protected] l URL: http://www.anveta.com
Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA
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