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Validation SOP Writer - Remote at Remote, Remote, USA
Email: [email protected]
From:

pankaj,

Stellent IT

[email protected]

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Validation SOP Writer

Remote

Phone and Skype

Long Term

Job Description:

Our client is seeking an SOP writer, currently there are no SOPs or QMS systems that exists. Client manager will provide the templates for the SOPs, just needs someone to plug the information into the template.

Responsibilities:
Develop, revise, and maintain SOPs and associated documentation, ensuring adherence to regulatory requirements, industry best practices, and company standards.
Specialize in 21 CFR 820 compliance and ensure that all SOPs are aligned with applicable regulations and standards.
Utilize templates and standardized formats- Hiring manager will provide templates in which the consultant will use to create the design process and design control.
Collaborate with the Quality team to develop and implement audit and inspection-ready documentation practices.
Assist in the creation and maintenance of the Design Control processes and procedures, ensuring alignment with regulatory requirements

Requirements:
Minimum of 3 years of experience in SOP writing within the medical device industry.

understanding of 21
CFR 820 compliance requirements and experience developing SOPs for QMS systems.
knowledge of medical device regulations and standards, such as ISO 13485 and FDA guidelines.

Keywords: information technology
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Mon Aug 28 21:11:00 UTC 2023

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