- 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
- Cipla (Hauppauge, NY)
- …8:30AM - 5:00PM Job Overview: The QA Associate (IT) is responsible for review of batch production records, ensuring that all documentation complies with Good ... produced according to the approved methods and specifications. Responsibilities: Review batch production records (BPRs), including associated documents (eg,… more
- Bayer (Whippany, NJ)
- …assist with any corrective or preventative actions (CAPAs). Proactively reach out and review the Audit Plans, make relevant organizations aware of upcoming ... & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports Medical Governance processes enabling cross-functional teams to be… more
- Cipla (Fall River, MA)
- …purpose of the IT - QA Associate position is to accurately review the chronological record of Laboratory Instrument/Equipment electronic data related activities that ... compliance to 21CFR, Part 11 requirements. Conduct regular audits of the audit trail to identify any irregularities or potential issues. Additionally, routinely … 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
- 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)
- …Major Activities / Tasks Monitor and control planned production by daily activity review as per p packaging plan to meet packaging targets and quality standards ... Review planned production vs. actual production daily and control...rectify issues related to facility management and documentation for audit readiness Handle investigations, OOS, OOT, change controls, deviation… more
- Cipla (Central Islip, NY)
- …control documents Review of system records Perform activities related to periodic audit trail review of all quality softwares, ensure compliance within the ... the ability to collaborate cross-functionally and communicate effectively. Responsible for QA review and approval of the following types of documents: SOP's GMP… 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
- Merck & Co. (North Wales, PA)
- …drug distribution (Oncology group purchasing organizations, wholesalers, and specialty pharmacies). Review and evaluate patterns for products purchased and prescribed ... Management (CRM), Customer Service, Healthcare Sales, Interpersonal Relationships, IS Audit , Lead Generation, Lead Generation Management, Market Analysis, Medication… more
- Cipla (Hauppauge, NY)
- …and set standards to meet the regulatory requirement and to ensure audit readiness : Ensure proper receipt, verification, segregation, storage, labelling and ... ensure clearance of items before expiry to control the cost of inventory Review the non-moving, low shelf life items periodically and ensure timely disposal… more
- Cipla (Fall River, MA)
- …set standards to meet the regulatory requirement and to ensure audit readiness. Ensure proper receipt, verification, segregation, storage, labelling and accounting ... ensure clearance of items before expiry to control the cost of inventory. Review the non-moving, low shelf life items periodically and ensure timely disposal… more
- Merck & Co. (North Wales, PA)
- …will establish a process and cadence of Governance to ensure appropriate oversight, review , and audit of supplier performance from site operations to Executive ... with our Company's Performance Targets.- Lead and manage the measurement and review process that ensures delivery of on-going improvement. Contract Management and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …review & material release in SAP for In-house reagents.Support Floor Spot-check, audit trail review .Strive to reduce non-conformances in supported areas by ... provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices… more
- Merck & Co. (North Wales, PA)
- …channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient ... Digital Analytics, Healthcare Innovation, Healthcare Sales, Interpersonal Relationships, IS Audit , Lead Generation, Lead Generation Management, Market Analysis, Medical… more
- Merck & Co. (Durham, NC)
- …Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment.Develop training material. Working as a subject matter… more
