- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Our Company's Corporate Audit and Assurance Services' (MCAAS) provides value-added independent and risk based audit , ... incumbent will need to possess a solid mix of audit and business operations experience in a multitude of...be to participate in the execution of IT internal audit engagements to assess the adequacy of internal controls… 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
- 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
- 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
- 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)
- …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)
- …CoE RMP process and proactively manage the resource model and timelines- Support CoE Audit Inspection Plan:Manage and establish a GOMA CoE Audit Inspection Plan ... in partnership with QA and relevant stakeholders across functions, geographies and levels of the organizationEnsure proper end-to-end documentation focusing on operational effectiveness and efficiency by building and maintaining a repeatable and standardized… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …applicable Daiichi Sankyo and regulatory requirements.Supports any external data related audit requests for assigned DS Programs / Studies; communicates to Vendors ... all / any problems related to data transfers, data structure deviations or validation issues.Complies with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Job Summary:The Compliance Intern will provide support to the Internal Audit function as well as provide other project support to the ... Training and Monitoring and investigations teams. Under the direction of the Audit function, this position will perform compliance, financial, and operational audits… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in support of a proactive quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to ... the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality) and in close collaboration… more
- Aequor (Thousand Oaks, CA)
- …and contracted services. - Provide training for staff, clients and projects, audit support, reviews and technically approves maintenance reports, forms, plans and ... records, develops, revises, and reviews equipment, maintenance or other related procedures, Interpret and revise loops sheets, electrical schematics, P&ID's, I/O wiring and panel drawings Routinely perform moderately-complex to complex processes according to… more
- Aequor (Seattle, WA)
- …File and maintain training records for easy retrieval. Partner with the inspection/ audit subject matter expert to generate LMS reports and/or retrieve training ... records to support inspections/audits Build and/or run reports to show user status or other requested information. Apply LMS knowledge to provide front line technical support (or escalation) for users. Thoroughly research customer requests and questions and… more
- Novo Nordisk Inc. (Atlanta, GA)
- …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
- Novo Nordisk Inc. (West Palm Beach, FL)
- …for ensuring and tracking compliance with regulatory/legal mandates Review and audit direct reports' expense reports. Exercise prudent control of field expenses ... Ensure timely and accurate submission of other administrative requirements Physical Requirements 50-75% overnight travel required. Driver must maintain a valid driver's license. Must be in good standing by not exceeding the Novo Nordisk points threshold… more
- Merck & Co. (Durham, NC)
- …ensure required Safety guidelines are followed and participates in divisional Safety Audit activitiesManages equipment location and status in SAP as well as related ... equipment drawings.Assists in deviation investigations for maintenance instruments, equipment, and systems. Collaborates/Executes with the reliability engineers periodic RBAM assessments and owns area specific reliability actionsCollaborates with Automation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of systems with cGMP's. Assists with preparation of yearly Facilities budget, audit and approval of contract Facilities services, performance reviews and on-call ... scheduling. Relationships Reports to: According to the organizational chart Number of subordinates with direct/indirect referral: see organizational chart Essential Functions Coaching and mentoring of direct reports Drive facilities performance to meet… more
- Catalent (Philadelphia, PA)
- …by supporting activities of the Manager, Quality Systems which may include audit support activities, GMP training and Compliance Wire support.Assist hiring managers ... with new hire preparation.Facilitate and maintain new hire orientation to meet the needs of new hires, promotions, internal transfers, external transfers and bubble assignments.Deliver trainings as needed and/or work with other internal or external resources… more
- Merck & Co. (Rahway, NJ)
- …target dates.Review and/or approve regulatory permits, inspection outcomes and audit report findings to assure appropriate submission, impact, and/or ... action.Develops/oversees solutions and reports status readily to executive management.Anticipate, recognize and respond to changing internal and external trends, market conditions, regulatory legislation, etc., evaluate and integrate the information to define… more
- Catalent (Philadelphia, PA)
- …and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory, and ... customer requirementsSupport Corporate and local Quality policies and initiatives. Support compliance for USDA, HHS, state, and foreign regulatory bodiesAnticipates internal and or external business challenges and/or regulatory Issues; recommends process,… more
