- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the...of GxP audits assigned in alignment with the Master Audit Schedule using a risk-based approach to ensure the… more
- Jazz Pharmaceuticals (San Jose, CA)
- …As a member of the REMS Strategy and Operations department, the Senior Manager , REMS Data Programmer will provide support for FDA mandated Risk Evaluation and ... technical solutions align with business requirements and stakeholder needs. Ensure audit preparedness and support regulatory inspections for REMS. Support daily… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, ... capital as well as recommend favorable debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management ... established metrics Prepare and present regular reports on documentation compliance, audit results, and improvement initiatives to senior management Lead continuous… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position We are seeking a detail-oriented and passionate Training Manager to join our Clinical, Medical, Regulatory (CMR) group at Novo Nordisk. ... submissions, and medical communications Ensure training programs meet regulatory audit requirements and maintain comprehensive training documentation Support preparation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …SDEA templates meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company (safety) SOPs Business ... Partner Liaison: Liaises with suppliers and corporate partners on safety reporting and monitoring issues as appropriate Serves as primary contact, facilitator and communicator of information to other departments within NNI and NNAS concerning contracts,… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Manager , Finance Applications, is responsible for end-to-end solution design, implementation and ... testing for multiple IT initiatives.Support activities related to Internal & External audit , SOX, GDPR, etc. complianceWho You Are:7-10 years of experience with… more
- Cipla (Hauppauge, NY)
- …IT systems supporting manufacturing processes, with a particular focus on audit trail review, data integrity, and overall GxP compliance. Responsibilities: Perform ... detailed reviews of the equipment audit trails associated with batches during production. Verify that...policies, safety requirements, cGMP and SOP's. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Hauppauge, NY)
- …and other documents related to manufacturing processes. Ensure batch records are audit -ready and fully compliant for both internal and external audits (eg, FDA, ... GMP inspections). Assist audit teams by providing required batch documentation and responding...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Central Islip, NY)
- …5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background and ... other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating… more
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