- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional activities and Global QA activities. This position performs support tasks Head Global R&D PV QA and Global R&D PV QA Leadership members as well as ... advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … System [QMS] QA, PV /MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ... Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business...of the Strategy, and Vision and Mission of Global RD/ PV QA. Drive a culture of solution oriented and… more
- Randstad US (Trenton, NJ)
- …will be placed on overseeing Regulatory and Pharmacovigilance procedural deviations, CAPA , change control management activities and inspection readiness. ... responsibilities: - Support investigations, development of corrective and preventative action ( CAPA ) and effective measures for Regulatory and PV related… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Functional activities and Global QA activities. This position performs support tasks Head Global R&D PV QA and Global R&D PV QA Leadership members as well as ... advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … System [QMS] QA, PV /MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs. + Help ... Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business...of the Strategy, and Vision and Mission of Global RD/ PV QA. Drive a culture of solution oriented and… more
- Sanofi Group (Cambridge, MA)
- …to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management ** sits within Specialty Care MAP ... into a unified and simplified governance framework. Lead change management and Provide insights through MAP & PRIL &...and increase the accuracy of internal auditing. Accountable for CAPA resolution following an audit or inspection and act… more
- Merck (Columbus, OH)
- …Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team. CAPA Management Support + Ensures that all actions and ... and worldwide Regulatory Health Authority requirements. + Experience with delivering effective CAPA management solutions. + Experience with risk management … more
- Integra LifeSciences (Cincinnati, OH)
- …resolution and labeling for the Integra Cincinnati manufacturing location. The Manager will lead and collaborate with contractors and cross-functional groups across ... the organization to implement initiatives, projects and improvements as necessary. The Manager will partner with the operations teams to meet customer fulfillment… more
- PCI Pharma Services (Bedford, NH)
- …and shape the future of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation, the Process Validation Engineer III/IV is accountable for guiding ... validation activities such as Performance Qualification (PQ), Process Validation ( PV ) and Revalidation (RV) in support of cGMP pharmaceutical/medical device… more
