- Novo Nordisk Inc. (Durham, NC)
- …preferred Working knowledge of FDA requirements related to manufacturing & documentation (cGMP, cGDP) preferred Knowledgeable with Pharmaceutical / Chemical ... & Reliability / Asset Management Accreditation l (CMRP, CRL, AMP) or equivalent preferred Minimum of (5) years in engineering field with a focus in equipment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction of a ... Global Labeling Operations and Compliance leads to product high quality labeling documentation .Establishes Process Best Practices: Serve as a role model for less… more
- Catalent (Philadelphia, PA)
- …Supervisor will supervise the team and activities associated with batch record documentation , reviewing and approving batch records, and releasing batch records and ... and Catalent employee. The Role: Responsible for ensuring batch record documentation aligns with activities performed and is compliant against Catalent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred . Experience reviewing/auditing documentation including but not limited to: Batch Records, ... minimum of 2 years of experience with quality support in clinical manufacture is preferred . A minimum of 1 year of leadership experience is also required. Knowledge… more
- Merck & Co. (Rahway, NJ)
- …in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates with ... issues related to protocol conduct,-recruitment, retention, protocol deviations, regulatory documentation , site audits/inspections-and overall site performance.Identifies, assesses and resolves… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development experience required) in and out of Veeva CRM system.- Documentation : Document various system related documentations such as system configurations, data ... flow processes, test scripts, functional specification, training documentation , etc. Ensure document integrity and version control by leveraging SharePoint and/or… more
- Novo Nordisk Inc. (Durham, NC)
- …Performs quality review & approval of Change Requests (CR's) & other documentation (in conjunction with LoB). Performs archiving duties and QA presence & ... compliance with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation … more
- Merck & Co. (North Wales, PA)
- … preferred .Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project management principles is desirable.Lean Six ... of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …between Novo Nordisk Inc. (NNI) and NNAS departments for preparation of documentation necessary for submission of applications Maintain meeting documentation ... divisions Work with project associate on compilation of information and supportive documentation for FDA briefing packages Work with project leader and team to… more
- Merck & Co. (Rahway, NJ)
- …operations, process development activities, compliance investigations/change management, authoring of GMP documentation , and lead other staff in the pilot plant as ... readiness and execution activities. Prepare, review, and/or approve GMP Documentation as appropriate. Author/Approve Standard Operating Guidelines and Procedures.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary ... to review global policies, inspections and audit CAPAs, and vendor audit documentation .- Author, update and maintain Global DX Computer System Validation policies… more
- Shimadzu Scientific Instruments (Naperville, IL)
- …TO: Providing repair and maintenance support on assigned products. (Daily) Accurate documentation and reporting of all repairs and product failures and when ... improvement recommendations. (Daily) Timely submission of all required paperwork and documentation as required. (Daily) May complete in-house bench repair work from… more
- Merck & Co. (Durham, NC)
- …of SOPs and preventative maintenance plansWriting and maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities ... of equipment and mechanical condition of the equipmentPrepares technical documentation and preventative maintenance procedures when needed - Provides training… more
- Merck & Co. (Durham, NC)
- …review and approval of incursions, review and approval of batch record documentation , and Reports.Requires working high level of knowledge and experience in the ... and environmental monitoring matters.Review and approval of batch record documentation (electronic batch record comment resolution, autoclave records, review and… more
- Novo Nordisk Inc. (Durham, NC)
- …staffing or personnel issues & escalate to manager as necessary Ensure documentation meets GMP requirements Lead & manage maintenance activities & ensures preventive ... (5) years of experience in a manufacturing environment required, pharmaceutical manufacturing preferred May consider a High School Diploma or equivalent with a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge ... or similar degree required- PhD Biostatistics or similar degree preferred Experience Qualifications- 6+ Years of proven experience within pharmaceutical… more
- Eisai, Inc (Nutley, NJ)
- …Additionally, you manage regulatory compliance activities, maintain accurate documentation , and evaluate new system impacts. Organizational management involves ... and residual IT compliance risks using a risk assessment framework.Oversee documentation , implementation, and testing of IT compliance controls.Monitor IT compliance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and systems Perform and maintain housekeeping according 5S principles Testing and documentation of all new operating systems, software, and hardware prior to rollout ... degree, or Bachelor's degree in Information Technology or related field preferred . HDI CSR certified, preferable ITIL Foundation certified, preferable Technical… more
- Merck & Co. (Durham, NC)
- …and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control ... automation, validation and additional testing, as required.Responsible for written documentation of activities.Completes preventative maintenance and calibration work orders,… more
- Merck & Co. (Durham, NC)
- …and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control ... automation, validation and additional testing, as requiredResponsible for written documentation of activitiesEfficient and safe maintenance and repair of equipment… more
