Internal Auditor
2 weeks ago
GSK is seeking a highly skilled Internal Auditor to join our team in Rockville, MD. As an Internal Auditor, you will play a critical role in ensuring the site's compliance with regulatory requirements and GSK's internal policies.
Key Responsibilities:- Manage the site's Management Monitoring, Internal Audit, and Site Managed External Supplier Audit Programs.
- Provide guidance to the site on cGMP compliance and handle the coordination of CAPAs within MERP and VQMS for audit observations.
- Act as a Certified Lead Auditor during Rockville internal and external supplier audits.
- Generate and obtain approval for audit plans on an annual basis and hold meetings to review audit plans and findings.
- Issue internal and external supplier audit reports and review responses for adequacy.
- Ensure all internal/supplier audits are responded to in a timely fashion and track progress to ensure audit commitment dates are met.
- Assist in the preparation for and participation in regulatory agency inspections, corporate, and customer audits.
- BA/BS Degree
- 5+ years of GMP experience
- Must have audit experience
- Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and applicable regulatory requirements
- Developed auditing skills, including developing and executing an audit plan, preparing and using checklists, and following up on findings
- Certification as a Quality Auditor is desirable
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
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Medical Device QA Auditor
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1 week ago
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Regulatory Affairs Director
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Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...
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Senior Research Accountant
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Senior Accountant
2 weeks ago
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3 weeks ago
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3 weeks ago
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5 days ago
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