Overview
On Site
Full Time
Skills
Documentation
Risk Assessment
IQ
OQ
PQ
URS
FRS
Drawing
Collaboration
Teamwork
Test Cases
Business Rules
Regulatory Compliance
Business Process
GMP
Computerized System Validation
System Testing
Health Care
GxP
Organizational Skills
Multitasking
Analytical Skill
Problem Solving
Conflict Resolution
Communication
Attention To Detail
Supervision
Science
Technical Writing
Job Details
Responsibilities:
- Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports).
- Experience in validating GMP Lab systems and Equipment.
- Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
- Identify and escalate, as necessary project risks and issues to the CSVC Manager.
- Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs.
- Be able to prepare reports on defects and problems that arise during system testing.
- Have solid oral and written communication skills and teamwork skills.
- Be a good team player, able to meet deadlines and handle changing priorities.
- Have strong judgment capabilities to clarify requirements when necessary.
- Have the ability to work with cross functional teams.
- Have solid experience working with validated systems.
- Work with business representatives to ensure the test cases reflect business rules and processes.
- Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.
- GMP/Regulated lab, more than 5 years of CSV experience required.
- Technical writing Experience.
- Highly skilled in Computerized System testing and validation in the healthcare industry.
- Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11).
- Solid project organizational skills. Ability to multi-task.
- Must have strong analytical problem-solving skills.
- Excellent communication including written, verbal, and listening skills.
- Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
- BS in Science or Technical Writing Degree.
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