- Novo Nordisk Inc. (Durham, NC)
- …Process Support - OFP. Essential Functions Participate & provide feedback to international corporate validation process group Must be ability to work & communicate ... effectively across multiple local departments & multiple international production sites Perform & review system, equipment, utility, & process revalidation per… more
- Eisai, Inc (Raleigh, NC)
- …or site manufacturing changes in collaboration with Product Quality, Regulatory Affairs, and Technical Operations.Establish productive business relationships for ... interface experiences with the Finance, commercial Sales and Marketing organizations, regulatory affairs, and with third party manufacturers.Strong knowledge of … more
- Merck & Co. (Durham, NC)
- …external and internal network) to achieve results and optimize supply chain. International Experience - Ability to effectively engage and collaborate with diverse ... Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing development and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements. + Prepare recurrent and routinely requested ... developments. + Research regulations and guidelines and interact with domestic and international regulatory counterparts to provide effective regulatory … more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. + Maintain ... and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during...and support to management, as necessary + Domestic and international travel up to 5% may be required to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …including daily monitoring and excursion evaluation. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. + Maintain ... knowledge of current regulatory requirements and standards as they pertain to the...and support to management, as necessary + Domestic and international travel up to 5% may be required to… more
- Biomat USA, Inc. (Clayton, NC)
- …compliance with SOPs, applicable domestic regulatory agencies such as FDA, international regulatory agencies such as EMA, federal and state regulations. ... Would you like to join an international team working to improve the future of...conducting, and follow up commitments for internal audits and Regulatory Inspections (FDA, EMA, etc.) + Assist the Quality… more
- Valvoline Global (NC)
- …framework that enforces robust policies, standards, and controls. Ensure compliance with international regulatory and industry standards (eg, SOX, GDPR, PCI), ... and compliance goals, playing a pivotal role in meeting regulatory requirements such as SOX, GDPR, and other ...regulatory requirements such as SOX, GDPR, and other international cyber security standards and frameworks such as the… more
- Fujifilm (Holly Springs, NC)
- …* Proven Leadership Experience * Experience and Strong knowledge of US and international regulatory standards and ICH guidelines especially with regards to ... CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well… more
- GE Vernova (Wilmington, NC)
- …and seismic testing and qualification. + Experience in US and international nuclear regulatory affairs, licensing, laws, rules, regulations, guidance, ... applicable nuclear guidance, and industry standards. + Remain current on nuclear regulatory issues and system, component, and equipment product knowledge. + Use… more
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