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Job Details

Sr. QA GxP Specialist

Company: EPM Scientific
Location: Long Island
Reference: 163191/005
Closing Date: 27 Jul 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Sr. Specialist, QA GxP Computer Systems required for Mid-Sized Bio-Pharmaceutical Company * Sr. Specialist, QA GxP CSV | GxP Systems * Greater NYC Area | PA | Greater Columbus, OH Area A rapidly expanding, Quality oriented Bio-Pharma, specialising in combination products in the areas of sterile injectables and bone regeneration materials, is actively looking to speak with process-oriented CSV professionals to ensure the company’s GxP Computer Systems are implemented within GxP requirements. ...

Requirements:

Sr. Specialist, QA GxP Computer Systems required for Mid-Sized Bio-Pharmaceutical Company



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Sr. Specialist, QA GxP CSV | GxP Systems
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Greater NYC Area | PA | Greater Columbus, OH Area

A rapidly expanding, Quality oriented Bio-Pharma, specialising in combination products in the areas of sterile injectables and bone regeneration materials, is actively looking to speak with process-oriented CSV professionals to ensure the company’s GxP Computer Systems are implemented within GxP requirements.

The incumbent will be responsible for maintaining system inventory of GxP Systems used for the production and support of the sterile manufacturing facility. The working atmosphere will involve a multitude of exciting projects and cross-functional tasks with GxP, QA Compliance, and senior management teams.

Responsibilities:


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Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, IQ/OQ/PQ etc.
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Develop department SOPs and provide SOP review for new systems
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Perform scheduled reviews of existing GxP systems and delineate remediation plans for non-conformances
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Maintain GxP Systems records and updates

Qualifications:


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BS in a related field
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2 years experience with computer systems projects/implementations
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Familiarity with project management practices
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Familiarity with SDLC, GAMP5 for software implementation, (exp. With Argus a Plus)



Compensation:

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$70,000 – 90,000 + excellent bonus + excellent benefits

Apply for this job: Sr. QA GxP Specialist

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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