MF01-111124 QA Lab Equipment Qualification Specialist
Validation & Engineering GroupChapel Hill, NC, USjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionBachelor'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.
Job Opportunity
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
Qualifications :
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Equipment Specialist • Chapel Hill, NC, US