Validation Analyst - GXP

Job description

Job Description

Validation Analyst - GXP

Position Description
POSITION DESCRIPTION

he Validation Analyst has strong analytical skills and an understanding of the solution validation process across regulated and non-regulated areas. They can objectively evaluate information gathered from multiple sources, reconcile conflicts, break down high level information into details, and abstract up low-level information to a general understanding distinguishing user requests from underlying needs of the business.

Primary responsibilities include:

• Collaborates with clients, subject matter experts, and technical teams to establish the solutions validation vision for development, and implementation

• Demonstrates defining strategies and developing documentation for deliverables such as Validation Master Plan, CSV Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ), URS, FRS, Requirement Traceability Matrix (RTM), and Validation Summary Report for Labware LIMS system

• Develop Test Scripts and Execute Test Scripts in HPALM

• Demonstrates strong analytical skills and detailed understanding of solution validation processes including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.

• Serves as the conduit between the customer community (internal and external customers) and the services teams in which the validation deliverables flow.

• Defines models and interprets data within and between business activities.

• Documents complex business processes using a combination of diagrams and explanation.

• Identifies critical issues with ease.

REQUIRED QUALIFICATIONS TO BE SUCCESSFUL IN THIS ROLE

equired Skills: In addition to Primary Responsibilities

• CSV Validation Analyst for Life Sciences

• Labware LIMS Pharma template Experience, Core, Stability, EM & ELN

• HP ALM with Experience in Test Development & Execution

• Strong knowledge of the Microsoft Office Suite, specifically Excel

• Knowledge and experience using SharePoint Community Sites

• Demonstrated project and operations coordination experience

• Strong organization skills

• Exemplary Communication Skills, whether face to face, tele-conference, video or transient electronic communication methods (IM, Skype, SMS) and practical knowledge of best communication method to use for circumstances

• Attention to detail

Desired Skills: In addition to Primary Responsibilities and Required Skills

• Life Sciences and/or Healthcare experience

• Basic understanding of Microsoft Project

• Business analyst experience or understanding

Your future duties and responsibilities

Required qualifications to be successful in this role

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Skills

·  SQL

Reference

680259