- 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
- Merck & Co. (Durham, NC)
- …direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing product impact for EM events, ... providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, and… 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
- Eisai, Inc (NJ)
- …providers and managing service provider business relationships in alignment with global strategies. Review and approve Clinical Quality Assurance audit plans and ... minimum 7 years pharmaceutical/clinical outsourcing.In-depth understanding of GCP/GLP guidelines, audit processes and agency regulatory requirements.Excellent verbal, written and… 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
- 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
- Novo Nordisk Inc. (Minneapolis, MN)
- …of resources to ensure attainment of strategic account and NNI profitability goals Review and audit expense reports Market access planning: Assist in providing ... standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Development of People Ensure that reporting personnel… more
- Catalent (Philadelphia, PA)
- …tasks and making adjustments when necessary to meet commitments.Publish daily review /release schedule and completed work report for previous day; Takes initiative ... issues, metrics, batch records, etc; Respond to and investigate customer complaints. Audit for compliance as pertains to Catalent SOPs, regulatory, & customer… more
- Catalent (St. Petersburg, FL)
- … review , approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.Bulk Mfg Protocols and Reports (non-GMP, ... to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a)… more
- Catalent (St. Petersburg, FL)
- …deliver solutions. Furthermore, this position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification ... quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager… 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
- Aequor (Thousand Oaks, CA)
- …to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (eg, CD, ... experience in Quality Management Software systems (eg TrackWise, EDMQ, etc) Preferred Requirements Experience in audit / inspection support Technical writing skills 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and other identifying tags to assets to improve accessibility Monitor and audit assets to adhere to established governance standards; ensure process standards are ... reports to share with business content owners and governance stewards for regular review and update Provide training and ongoing support on the best practices of… more
- Novo Nordisk Inc. (WA)
- …retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external ... good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to work company holidays and… more
- Aequor (Tampa, FL)
- …. System Experience: Workday, ADP, Microsoft Office (Excel, Teams, SharePoint) Handle review and processing of employee leaves and/or the timely and accurate ... lining docs, auditing) Soft Skills: Time management Risk Identification Compliance/ audit and process optimization skills preferred Team Player/Collaboration Paralegal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as the overall process.Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data ... applicable Daiichi Sankyo and regulatory requirements.Supports any external data related audit requests for assigned DS Programs / Studies; communicates to Vendors… more
