Manage and create incoming Inspection Acceptance Activities and Final Release processes, including the creation and maintenance of inspection plans for parts / components using SAP Quality Module (QM) and electronic DHR system.
Execute audits and assessments of clinical investigational sites, clinical research organizations, institutional review boards, and pre-clinical sites, including ensuring the effectiveness of their quality assurance unit.
In this role, the selected candidate will perform all technical final financial statement review in addition to performing a variety of functions including audits, tax verses book adjustments, etc for a diverse group of private clients.
In this role, you will manage components of a comprehensive quality assurance program to meet the requirements of all agencies and regulatory bodies involved with mortgage servicing; rigorously test key procedures and controls within all key business units; monitor key indicators to detect and research unexplained variances which may be indicative of quality control issues.
Provide documentation review/approvals supporting external and internal teams to provide a high degree of assurance that sterile drug product programs will achieve regulatory approval, clinical release, and commercialization.
The Quality Assurance Manager is responsible for maintenance of Kashiv Pharmas quality management system, batch record review and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.
In this role, the selected candidate will support inspections by regulatory agencies by assisting in the organization of and preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections.
The Sr. Manager, QA, Contract Manufacturing manages and oversees the activities of external manufacturers to ensure products meet current Good Manufacturing Practices and Good Tissue Practices, applicable medical device regulatory requirements, and corporate quality and regulatory standards through interaction with business partners.
Develop technology strategies and multi-generational roadmaps, and implement solutions which enable and advance the data management and analytical capabilities/processes in alignment with relevant IT, Supply Chain, and Quality Strategies.
In this role, the selected candidate will build and lead the managed services team to support the following testing activities - Functional Testing, Regression, Integration Testing, End to End testing, User Acceptance Testing, Performance Testing and Test Automation.
Support the design and implementation of a robust and compliant global framework of GMP policies, directives, procedures and processes for the Global Supply Chain Security program, including Serialization, Track-and-Trace, Anti-counterfeiting and Product Authentication.
Build and lead the managed services team to support the following testing activities - Functional Testing, Regression, Integration Testing, End to End testing, User Acceptance Testing, Performance Testing and Test Automation.