Validation Engineer available for C2C immediately

[Durdana Pindi]

Hi All,

We have a Validation Engineer/Consultant with 4+ years experience available immediately.

Please contact me @ 2017439052 or mail me @ dak...@pindisolutions.com.

Below is the Summary,

Seasoned Quality Assurance/Validation specialist with extensive experience in the Pharmaceutical industry. Duties entailed ensuring and overseeing the compliance of computer systems with Federal, State, corporate and industry regulatory requirements and standards.
Experience in Quality Assurance, CAPA, Root Cause Investigations, and Change Management.
Extensive knowledge in a regulated environment (FDA, EU, MHRA, GAMP 5 and 21 CFR Part 210, 211, 11, 820, and ISO 13485, 9001 standards).
Authored SDLC deliverables such as Gap/Risk Assessments, Corrective Action Plans, Audits (vendor/third party/phone), Remediation/Validation Plans, Business Process Diagrams, Test Plans, Requirements Documents (User, Functional, Quality, Support and Maintenance, Security, etc.), Design and Configuration Specification, Test Protocols, IQ/OQ/PQ (author and executed), Traceability Matrix, Test Summary Log, SOPs, Validation Summary Report, etc.
Software Applications: Microsoft Word, Excel, PowerPoint, Access, Project, Outlook, FirstDoc, HPQC (HP ALM), LIMS, TrackWise, Oracle MES, Oracle EBS, Livelink, Virtual Link Manager (VLM), SharePoint, Collaboration Review (CRX) DocWay Publisher and Documentum.
Ability to work independently; self-starter; motivated; works well under pressure.
Dedication results-oriented professional known for highly-developed organizational skills, advanced problem resolution, flexibility, and high standards.


Thanks
Durdana