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- Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.
- Facilitate and host customer audits at the Catalent Somerset site to ensure compliance with cGMP's, as well as Corporate and site standard operating procedures.
- Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.
- Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities.
Participate in all aspects of inspections from initiation, preparation, execution through closure.
- Lead the internal audit program at the site.
- Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections.
Ensure responses are completed as committed.
- Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met.
- Initiate deviations when site procedures are not followed.
- Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness.
- Participates in the preparation of Supplier and Customer Quality Agreements.
- Participate in global supplier and regulatory meetings and effectively represent the site.
- Review and approve TrackWise Records as needed acting as a QA Representative.
- Review and revise departmental SOPs as required.
- Comply with Environmental, Health & Safety requirements.
- Other ad hoc duties as assigned.
Sr NERC Compliance Specialist - Operations and Planning
As a member of the NERC Compliance Group, you will perform governance and oversight of PSEG’s compliance with the NERC Operations and Planning Reliability Standards. Develop and adhere to PSEG NERC compliance internal control programs to ensure ongoing compliance and adequate preparation for NERC co...
Senior Regulatory Specialist
Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instru...
Regulatory Affairs Sr Manager – Personal Care and Cosmetics
Regulatory Affairs Senior Manager is responsible for leading the regulatory strategy and managing the regulatory compliance in Personal Care and Cosmetics. Collaborate with regulatory colleagues and support R&D, marketing and commercial efforts in all phases of ideation and commercialization for...
Invoicing & Compliance Specialist
Ensure compliance standards are reviewed and adhered to. Utilizing SAGE for entering, tracking and followup on invoices and POs. A leading supplier of pet products throughout the United States, Europe, South America, Australia and beyond. With a focus on unique designs, internationally sourced fabri...
Compliance AML Head of Risk Frameworks and Reporting, Sr. Director
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment rega...
Regulatory Affairs Specialist
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...
Compliance and Operational Risk Specialist - Credit Risk
Engages in activities to provide support to the Compliance and Operational Risk teams in order to provide independent compliance and operational risk oversight of Credit Risk performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the...
Sr Counsel, Privacy & Data Security Compliance – Ridgefield Park, NJ
Counsel and support Samsung businesses on privacy issues in connection with the development of products, platforms, services, and other initiatives involving the collection and use of consumer data, including business intelligence, advanced advertising, customer experience, and related business and ...
NERC Compliance Specialist - Operations & Planning
As a member of the NERC Compliance Group, you will perform governance and oversight of PSEG’s compliance with the NERC Operations and Planning Reliability Standards. Knowledge of Federal regulations with regard to electric reliability standards, NERC and the NERC Regional Entities and related indust...