- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for… more
- TEAM QUALITY SERVICES INC (Auburn, IN)
- …with onboarding new supervisors and assisting with on-the-job training.-- Coordinate with Manager for scheduling of inspection team members to ensure efficient ... more!)About this Position: A Level 1 Supervisor is expected to learn all TQS Inspection Processes and Procedures to ensure the correct execution of inspection ,… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- Job SummaryExecute plans, schedule, and expedite the visual inspection , labeling and packaging of parenteral pharmaceutical products to meet sales requirements ... Of Responsibility Directly oversee personnel through regular presence in the inspection /packaging areas to optimize performanceManage all kit inspection ,… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- Job Summary Execute plans, schedule, and expedite the visual inspection , labeling and packaging of parenteral pharmaceutical products to meet sales requirements ... Area Of Responsibility Directly oversee personnel through regular presence in the inspection /packaging areas to optimize performance Manage all kit inspection ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …surveillance and risk management for assigned clinical studies, through inspection readiness preparation Responsibilities - Risk Management (Signal identification, ... surveillance and risk management for assigned clinical studies, through inspection readiness preparation - Project Management: - Coordinates SMT/Product-level safety… more
- Novo Nordisk Inc. (Durham, NC)
- …performed in accordance with cGMP, NNPILP and corporate policies. Relationships Senior Manager . Essential Functions Lead team in successful execution of QC and ... activities based on assigned area of accountability Coordinate with the responsible manager and other teams on workload issues and priorities Plan weekly to… more
- Merck & Co. (Durham, NC)
- …drug products, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.--As the team finishes the design and ... construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, partnering with internal… more
- BioAgilytix (Boston, MA)
- …need them.We are seeking a highly organized and experienced Quality Assurance (QA) Manager with strong people management skills to lead our Boston team and ensure ... hosts sponsor audits and government agency inspections Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if… more
- Novo Nordisk Inc. (Durham, NC)
- …developing & executing tactical & strategic plans. Relationships Senior Manager , Facilities, Utilities, Systems, Equipment (FUSE). Essential Functions Develop, coach ... extremely cold work environments. Occasionally positions oneself within confined spaces for inspection , repair & maintenance of equipment. Ability to work in loud… more
- Insmed Incorporated (San Diego, CA)
- …QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks ... efficiency, productivity, and quality. Maintains and monitors accreditation and inspection standards, keeping the laboratory in compliance with regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supply forecast of commercial and IMP drug product. Supports regulatory inspection and its readiness. Works diligently with CMO representatives and analytical ... labs in order to ensure the compliance for activities performed. Provides accurate and timely information for leadership to support the decision-making process. Qualifications: Successful candidates will be able to meet the qualifications below with or without… more
- Eisai, Inc (Nutley, NJ)
- …CAPAs of system audits. Support health authority audits/inspections for inspection readiness. Requirements Bachelor's degree in associated functional disciplines ... including IT, Data Sciences and others.Software development familiarity with both Agile and Waterfall methodology.Knowledge of coding matrix and complexity measurements/determination.Minimum 8 years experience in Pharmaceutical industry or similar.Familiarity… more
- SYSCO (Bellevue, NE)
- …compliance of all Company programs, including preventative maintenance and inspection of vehicles, non-scheduled maintenance and troubleshooting, repair, rebuild and ... overhaul of vehicles.Review fleet maintenance functions and various operational and expense reporting.Suggests efficiency ideas, cost reduction measures and assists with the implementation of changes within fleet maintenance.Conducts audit daily to ensure all… more
- Novo Nordisk Inc. (Durham, NC)
- …engineering teams & stakeholders, management of vendor & service contracts. Relationships Manager or Senior Manager . Essential Functions Lead reliability program ... extremely cold work environments. Occasionally positions oneself within confined spaces for inspection , repair & maintenance of equipment. Ability to work in loud… more
- Novo Nordisk Inc. (Durham, NC)
- …production goals, while adhering to applicable cGMPs & SOPs. Relationships Shift Manager . Essential Functions Setup, operate, monitor & control equipment, systems & ... work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , and quality control laboratories. The Quality Assurance Specialist will ... performance objectives.Consults on an as-needed basis with next level manager on more complex decisions.Education Minimum Requirement:Bachelor's and/or Master's (or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and relocation assistance package is available. Relationships Reports to: Manager , Automation Engineering Number of subordinates with direct/indirect referral: none, ... close activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical conditions including:… more
- Novo Nordisk Inc. (Durham, NC)
- …Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Senior Project Manager - OFP. Essential Functions Coach & mentor peers, Engineering personnel ... work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments… more
- Novo Nordisk Inc. (Durham, NC)
- …People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Senior Project Manager - OFP. Essential Functions Support plans to maintain & improve ... work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments… more
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