- Merck & Co. (Rahway, NJ)
- …to what is described in the Pipeline Advertisement.Expand your skills and experience in audit through a career path in the pharmaceutical industry. Become part of a ... a positive impact on patients' lives.Under the direction of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:Participate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …need for change request; manage interactions with Vendor, finalize execute amendment.- Audit Ready/Inspection Prep: As per the audit requirement and processes, ... all times; these documents must be clearly filed and retrievable. Perform quality audit on procurement documents filed by the RD Procurement team, periodically, to… more
- Catalent (Manassas, VA)
- …and leadership for the regional Supplier Auditor Team performing audits, generation of audit reports and management of supplier CAPA to ensure required actions are ... regional team performing the audits assigned develop a planned audit schedule to maximise audits conducted during one trip...of metrics to provide visibility of audits due, planned audit dates, Audits complete, Audit reports process… more
- Catalent (St. Petersburg, FL)
- …and oversight. The Quality Auditor will be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed ... performing the audits assigned and to develop a planned audit schedule to maximize audits conducted during one trip...actively with the Catalent sites to manage and conduct Pre- Audit Preparation activities with an understanding of requesting sites… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …tasks.Develop the performance/talent of direct reports.Schedule, staff, train, and audit multiple activities for responsibilities.Ensure completion of all testing, ... important to pharmaceutical and combination drug manufacturing labs.Help with plant audit ready status efforts for assigned areas and participate in internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …during regulatory agency inspections and vendor audits.Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities ... Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE's/CAPAs.CQA representative for… 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 compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit Support- Partner with DSI Finance Business Partner to maintain and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …processing and compliance reporting processes and take lead role in the audit /inspection process (eg, prepare pre- audit requests, perform document review, coach ... auditees, manage document requests, front room auditee, messenger, scribe) Collaborate with Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actions… more
- Eisai, Inc (Nutley, NJ)
- …compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite ... information security, or business continuity management certification is advantageous.Prior audit /assurance experience is helpful. Information Technology and Compliance Experience… more
- Eisai, Inc (NJ)
- …in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond to internal audits and corrective ... minimum 7 years pharmaceutical/clinical outsourcing.In-depth understanding of GCP/GLP guidelines, audit processes and agency regulatory requirements.Excellent verbal, written and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …updated to ensure appropriate taxation Generate reports as needed for audit , tax, and legal/regulatory filing purposes globally Maintain documentation of assigned ... processes related to equity administration Partner with Group Internal Audit (GIA) to ensure and demonstrate internal controls are in place and executed Establish… more
- Catalent (St. Petersburg, FL)
- …drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.Bulk Mfg Protocols and Reports ... regulatory audits.Engage in monitoring quality systems to maintain awareness and audit /inspection readiness at all times.Ability to investigate and analyze technical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit documentation.- Author, update and maintain ... Global DX Computer System Validation policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements 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 ... for local SOP's and SOI's.Support Quality personnel as part of audit activities of manufacturing, facility, and quality controls areas and operations.Review… more
- Radisson Hotel Portland Airport (Portland, OR)
- …providing exceptional service to our guests while accurately performing night audit procedures.Position Information: Full-time, 17.00 hourly rate. Please note this ... the update process on the front office system following guidelines.Balance and audit all front desk postings and settlements.Reconcile food & beverage 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 ... to developing, conducting, and reporting the Compliance Monitoring Plan (eg, utilizing monitoring tools/reports, field monitoring and analytics).Annually evaluate and revise the CM plan as necessary.Identify areas of potential non-compliance and assist in the… 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 ... being followed for managing assets Generate appropriate taxonomy/metadata 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 content import and… more
- BioAgilytix (San Diego, CA)
- …as directed by clientProvides information for QAU, client, or regulatory agency audit reports as neededGenerates and maintains records in a GxP compliant ... mannerAssists in collecting metrics data as neededRecommends process improvementsMay receive samples as needed:Receives shipments into Sample ManagementInitiates sample chain-of-custodyProvides timely notification of sample receipt to client/BPMMay manage… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external ... stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within… more
- Merck & Co. (Rahway, NJ)
- …and various other-systems as appropriate and per timelines.Supports audit /inspection activities as needed.Performs co-monitoring where appropriate.Extent of ... Travel-Ability to travel domestically and internationally approximately 65%-75% of working time.-Expected travelling ~2-3 days/week.-Current driver's license preferred.Qualifications, Skills-& Experience-Competency Expectations:Fluent in Local Languages and… more
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