QA Lab Equipment Qualification Specialist
1 week ago
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.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
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
- 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.
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