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Validation & Engineering Group, Inc.

MF01-111124 QA Lab Equipment Qualification Specialist

Validation & Engineering Group, Inc., Carolina, Carolina, us, 00985

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Validation & Engineering Group, Inc.

(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

QA Lab Equipment Qualification Specialist

Help document the necessary specifications for the equipment to purchase.

Basic knowledge of laboratory equipment and its use.

Basic knowledge of document control systems (such as Cdocs or Veeva Vault).

Write design documents, including Qualification Plans and Design Qualification Reports.

Write and execute qualification documents, such as Installation and Operational Qualification and Performance Qualification.

Write and execute equipment decommissioning documents.

Qualifications

Bachelor's Degree in Science or Engineering.

Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.

Must be fully bilingual (English / Spanish) with excellent oral skills.

Strong knowledge in cGxP and regulatory guidance and compliance.

Experience in the development of SDLC Documentation Risk Assessment, URS, VP, DS, TMX, IQ, OQ, PQ protocols development and execution, deviations and reports generation.

Technical Writing skills and investigations processes.

Available to work extended hours, possibility of weekends and holidays.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Strategy/Planning and Information Technology

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