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Senior Validation Analyst

Job Description

· Perform hands-on execution of validation testing on instruments, equipment, and computer systems to be in compliant with FDA regulations like 21CFRPart11.

· Follow GAMP5 practices for authoring and reviewing Validation Documentation.

· Perform Regulatory Assessment and Criticality Assessment following the Good Laboratory/Good Manufacturing practices and analyze their impact on Patient Health, Product Quality and Data Integrity.

· Develop and/or review/approve various types of system validation lifecycle documentation (Validation Plans, User Requirements and Functional Requirements Specifications, Design Specifications, User Acceptance Tests (UAT), Design Qualification (DQ), IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports).

· Perform Data Integrity assessments, gap assessments, formulate options and action plans, execute action plans, remediation activities, etc. as assigned.

· Track status of all deliverables and provide management updates. Meet required quality system and project timelines.

· Perform QA oversight of GxP computerized system validation activities to ensure they are in complaint with FDA regulations.

· Conduct GxP assessments, risk assessments, part 11 assessments.

· Responsible for maintaining up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP5, industry standards, policies, and procedures.

· Review/Revise of Standard Operating Procedures (SOP).

· Perform periodic reviews of computerized systems.

· Support the development of procedures, work instructions, validation templates and training materials to ensure that the control of GxP computerized systems is integrated into Quality Management System.

· Provide support in other quality system related activities including quality exceptions and change control.

 

 

Qualification:

 

This position requires a minimum of Bachelor’s Degree in Pharmacy or a closely related field.



Job Tags

SOP, Senior Validation Analyst, Validation Analyst, GxP, IQ, OQ, PQ, UAT, FDA
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 11/22/21 5:20 PM
· Perform hands-on execution of validation testing on instruments, equipment, and computer systems to be in compliant with FDA regulations like 21CFRPart11. · Follow GAMP5 practices for authoring and reviewing Validation Documentation. · Perform Regulatory Assessment and Criticality Assessment following the Good Laboratory/Good Manufacturing practices and analyze their impact on Patient Health, Product Quality and Data Integrity. · Develop and/or review/approve various types of system validation lifecycle documentation (Validation Plans, User ... read more