- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier ... qualification program, CMC audit , clinical/IMP vendor audits and overall GMP vendor ...risk management activities completion for vendors and to periodically review vendor performance in order to ensure the management… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational execution ... of the company's Global We're looking for an Associate Director, Medical Review Committee Operations, on the Medical Review team to help us expand what's… more
- Outlier AI (Fort Worth, TX)
- …phases, lower rates may apply. Certain projects offer incentive payments. Please review the payment terms for each project. Equal Opportunity Employer: Outlier is ... committed to fostering a diverse and inclusive work environment. We welcome applicants from all backgrounds and celebrate diversity in our workforce. xhqgsiq Remote working/work at home options are available for this role. more
- Merck & Co. (Durham, NC)
- … execution ( audit pre-work, conducting audit , issuance of audit report, CAPA review and verification) meet established expectations. Perform, lead, ... mentor other auditors during site audits; participate in opportunities to audit at regional sites Review , and approve Audit Reports Actively monitor, report… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance initiatives, such as inspection readiness, metrics implementation and review , overall regulatory compliance and implementation programs, and others as ... all sites.Manage and support the implementation of the internal and external audit program.Schedule, execute, report and follow-up on internal and US and Global… more
- Cipla (Fall River, MA)
- …(eg, quality metrics, CAPA (Corrective and Preventive Action) reports, audit findings). Support investigations of deviations, non-conformances, and customer ... with TrackWise applications for handling Deviation and CAPA. Prepare and review the investigation related to deviation, OOS, market complaints and microbiological… more
- Merck & Co. (Omaha, NE)
- …audits of our Company's global export and import operations and generate audit reports.Assist local sites in developing robust CAPA plans with realistic ... implementation timelines. Review and approve evidence of CAPA completion to ensure...regulations and assist in the development of policies and standards. Audit experience and skills desired.Strong project management experience and… more
- Cipla (Fall River, MA)
- …standards for completeness of the labels against standard operating procedures (SOPs). Review of laboratory audit trials during data review ... of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring… more
- Cipla (Fall River, MA)
- …new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against ... / comparison reports and any other study reports. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. Verifying… more
- Merck & Co. (Rahway, NJ)
- …you'll doLead the monthly, quarterly, and annual close for US entities: Review and approve journal entries and account reconciliationsPrepare and analyze period-end ... Business Services on close and reporting mattersAudit support:Respond to audit inquiries, and support internal/external auditorsLeadership and development:Provide day-to-day… more
