Validation Analysis Trainer
We are looking for a qualified Validation Analysis trainer to guide and prepare our fresh batch of trainees for the challenges faced in real-time. The training has to be provided on an online medium as per the U.S Eastern Time zone.
• Minimum 5 years of experience as a Validation Analyst.
• Outstanding verbal and written communication skills.
• Creating training material (Power point presentations) for the trainees will be part of the training.
• MS Office proficiency is a necessity.
• Experience writing Standard Operating Procedures and validation policies.
• Training material should be prepared before the first Online-session.
• Must have Team Viewer and Go To meeting installed.
• Should have a high speed Internet connection with a clear noise free environment (absence of this is a deal breaker).
• At least one year of experience using SQL on Oracle or SQL Server is required.
• Knowledge and experience using automation testing tools like Selenium.
• Information Technology background, experience within a Quality/Regulated environment will be a plus.
The trainer should be able to explain following topics (and more) with ease,
• 21 CFR Part 11, 210, 211, 820 and good understanding of cGxPs (cGMP, GLP, and GCP).
• Software development life cycles (SDLCs) like Waterfall, Agile and V-models.
• Reviewing, and modifying of documents related to Computer Systems Validation Lifecycle (CSV) such as - Validation Master Plan (VMP), Standard Operating Procedures (SOP's), Installation Qualifications (IQ's), Operational Qualifications (OQ's), Performance Qualifications (PQ's) and Validation Summary Report (VSR) and designing Requirement Traceability Matrix (RTM).
• Technical Writing with strong experience in developing Enterprise Lifecycle Documentation required for application development projects like Project Plan, URS, FRS, FDS, RTM, Test Plan, Test Cases and Support Plan.
• CAPA Analysis and writing Remediation Plans.
• Validation of Laboratory Information Management System (LIMS), TrackWise, Change Control Management System (CCMS).
• Adverse Event Reporting System (AERS) Spreadsheet and Report Validation. Well versed in performing Gap Analysis, Risk Assessments and classification of System into various GAMP (including GAMP 5) categories using Impact Assessment.
• System Audit/Validation background/experience.