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Regulatory Compliance Associate
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Pharmaceutical industry today.
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Regulatory Compliance Associate : GlaxoSmithKline
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| Job Number |
72646 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Memphis
Tennessee
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
12/27/2011 |
| Industry |
Pharmaceutical |
| Job Type |
Quality-Assurance |
| Relocation |
Not Required |
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| Description |
Basic Qualification
? 5 years experience in cGMP environment
? 4 year experience in a Compliance role with auditing responsibilities preferred
? Bachelor of Science Degree
? Detail oriented, problem solving skills, ability to multi-task
? Interpersonal, written and oral communication skills
? Proficient in Microsoft Office Programs
Details
GlaxoSmithKline (GSK) Memphis is located in the heart of Tennessee. We are surrounded by “Blues” legends, rich historical landmarks and southern charm. The Memphis site is a part of the Consumer Healthcare business, and is in the Global Manufacturing and Supply Division of GSK. At the present high speed manufacturing and packaging of powders and tablets, in addition to several other regional/national brands is the focus of the site. The production floor is highly automated, and the site operates 24/7.
? The Regulatory Role exists to extend the scope and effectiveness of site compliance.
? The Regulatory Role exists to support the Regulatory Compliance Supervisor so that QMS may be adequately structured and effectively implement throughout all of the site operations.
Accountability:
? Planning, scheduling, conducting supplier audits as available
? Planning, scheduling, and conducting internal site audits (Level II) as available
? Participating as part of the host inspection team for all Regulatory audit at the Memphis site as available.
? Performing the duties as a scribe during Regulatory and internal audits as available.
? Write all annual product reviews and make recommendations to the site leadership for improvement or other required actions as a result of the process
? Write and manage all Technical Terms of Supply Agreement with markets serviced by the Memphis site.
? Assist Quality Manager/ Regulatory Compliance Supervisor with all Quality Councils as available
? Write and negotiate all Technical Terms of Supply with the required receiving markets.
? Updating and managing CARISMA II entries as required |
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| Requirements |
Preferred Qualification
Auditing experience |
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| Contact Info |
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