- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analytical approaches (eg, identification of outliers to focus monitoring/ audit activities).Responsibilities Compliance Monitoring Responsible for activities ... support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for GDP requirements, risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are ... audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within CSPV function. Improve QA engagement with CSPV at… more
- Catalent (Philadelphia, PA)
- …and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory, ... management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will… more
- Catalent (Philadelphia, PA)
- …questions, issues, metrics, batch records, etc; Respond to and investigate customer complaints. Audit for compliance as pertains to Catalent SOPs, regulatory, & ... will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide...and ensuring that all functions are being performed in compliance with SOPs. This is a full-time position: Monday… more
- Aequor (Tampa, FL)
- …(red lining docs, auditing) Soft Skills: Time management Risk Identification Compliance / audit and process optimization skills preferred Team Player/Collaboration ... data integrity for all HR systems and databases within the required Compliance framework. Synthesize various reports using MS Excel or similar. Provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …back room activities for health authority audits and independent audits; manage audit responses and observation resolution. Drive site compliance to regulatory, ... to the site Ensures and maintains a state of inspection readiness. Perform compliance walkthroughs as part of audit /inspection readiness activities to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes, ensuring that these advancements result in more effective and efficient audit responses. Tax Reporting and Compliance Innovation: Oversee and innovate ... identify areas for system improvements and enhancements. Retirement Plan Oversight and Compliance : Manage and audit retirement plan contributions, ensuring … more
- Eisai, Inc (Nutley, NJ)
- …risks to an acceptable level.Manage IT compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and ... information security, or business continuity management certification is advantageous.Prior audit /assurance experience is helpful. Information Technology and Compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and ... & investigations, 3rd party/vendor oversight and liaison to support audit and inspections as applicable. Support MA/PV health authority inspections… more
- Catalent (St. Petersburg, FL)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. The ... and oversight. The Quality Auditor will be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed… more
- Catalent (St. Petersburg, FL)
- …Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. As ... and leadership for the regional Supplier Auditor Team performing audits, generation of audit reports and management of supplier CAPA to ensure required actions are… more
- Merck & Co. (Rahway, NJ)
- …all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The ... activities during the preparation / ongoing / follow-up phase of an audit or inspection.In cooperation with local CCQM, local country operations and/or headquarters,… more
- Aequor (Bothell, WA)
- …experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with at least 3&plus years in a leadership position. ... management of e-systems used across the site operations are conducted in compliance with applicable Data Integrity related regulatory requirements (FDA, EMA, etc)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to dive into different functions of GMP QA Department such as Audit , Quality Management System, Pharma Product, External Supplier Management and Strategical ... new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance , internal/supplier auditing, or customer focus activitiesPerforming the necessary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality departments… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to existing GCO procedural document packages.As needed, monitor 1) procedural compliance metrics to support inspection readiness activities, and 2) procedural ... appropriate, provide support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a new procedural… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Key ... a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations. Wear the appropriate PPE when working in manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document and manage records for corrective and preventative actions, ensuring compliance with regulatory standards. Draft, review, and approve Standard Operating ... Procedures (SOPs) for equipment operation. Conduct regular reviews of system audit trails / periodic review to ensure data integrity and compliance . Manage… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... the QA Specialists. The role is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes associated with legal and financial requirements including handling internal audit . Work closely with IT regarding implementation and utilization of new ... trends, and variances to ensure acceptable business practices, procedures and compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit… more
