Job Description

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.
• 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 system owner to ensure the test cases reflect system functionality and intended use.

Requirements:

• BS in Science or Technical Writing Degree
• 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

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