- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within ... risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits...to stakeholders via the QMS scheme (ie, Quality Management Review , Quality Review Board) across the global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procurement documents filed by the RD Procurement team, periodically, to ensure audit readiness. Review interpret stored documents show appropriate information ... needed.Responsibilities- Contract Coordination: Collate exhibits to create contract draft, Review contract documents for completeness and accuracy; Ensure compliant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for the creation, management, and documentation of GCO's CRO SOP review and maintaining the master Daiichi Sankyo (DS) SOP list for ... the ownership and maintenance of GCO-owned procedural document packages.Lead authoring, review , and periodic reviews/updates for all GCO procedural packages and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: Manages ... external stakeholders to complete deviations in a timely manner.Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments. Additional medical writing ... implemented. Liaise with CRO to support database lock and review of TLG before and after database lock.Ensure DS...Lead. Coordinate and liaise with Daiichi Sankyo QA on audit activitiesProvide oversight of the transmittal of trial and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to dive into different functions of GMP QA Department such as Audit , Quality Management System, Pharma Product, External Supplier Management and Strategical ... collaboration for local SOP's and SOI's.Support Quality personnel as part of audit activities of manufacturing, facility, and quality controls areas and operations.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance, and global Quality expectations. Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor ... or qualification of global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols (IQ/OQ/PQ), Test… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes associated with legal and financial requirements including handling internal audit . Work closely with IT regarding implementation and utilization of new ... and resolving matters of confidentiality. Coordinating a budget planning and review meeting with Finance Business Partner, Function Head and stakeholders. Partner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee ... PSL(s) or Clinical Safety Physician(s) for assigned product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design, participate in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review ... medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …input into study protocol profiles, final protocols and amendments.Lead document review & coordination for the protocol and amendments. Additional medical writing ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Successfully support the implementation, execution, and improvement of the internal audit process. Support the planning and execution of internal audits for ... all quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through...team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements. Develops… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the scrutiny and questioning of a sponsor pre-approval inspection.Post inspection, audit , quality review , investigational panel or other identified sources, ... gather, analyze, prepare and present on lessons learned / best practices to the GCO platform and other key stakeholders, in collaboration with RD QA or other relevant stakeholders. Work in a mindset of being a learning organization. Strategic Planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analytical approaches (eg, identification of outliers to focus monitoring/ audit activities).Responsibilities Compliance Monitoring Responsible for activities related ... all monitoring activities and results.Conduct field-based (live) monitoring, records review , and data-based monitoringData analytics Maintain/revise current monitoring tools/reports,… more
- Eisai, Inc (Nutley, NJ)
- …track KPIs.Define critical processes and manage recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk-based ... compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite… more
- Insmed Incorporated (Bridgewater, NJ)
- …for troubleshooting support. Additionally, the role includes tasks related to audit support, training, and diligent tracking of complaint data. Overall, this ... of Product Quality Complaints metrics for monthly trending, management review meetings and process improvement closure, presenting and communicating trending… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Standard Operating Procedures (SOPs) for equipment operation. Conduct regular reviews of system audit trails / periodic review to ensure data integrity and ... compliance. Manage equipment access rights and perform periodic reviews to maintain security protocols. Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and CSV (eg, GAMP 5, USP , 21… more
- City of New York (New York, NY)
- …Services Program (HCSP) is recruiting for one (1) Accountant II, to function as an Audit Reviewer in the Home Care Contract Management Services Unit, who will: - ... Review audit reports for accuracy and compliance... Review audit reports for accuracy and compliance with prescribed ...Interface with CPA firms to ensure correct resolution of audit discrepancies, review requests for extension of… more
- City of New York (New York, NY)
- …participate in all medical record reviews /audits following established ACS medical audit protocols. The Nurse Reviewer will also conduct targeted, unannounced ... and initiatives that support best case practice agency wide. The Medical Review Authorization and Monitoring Unit (MRAM) reviews foster care medical records and… more
