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.
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.
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.
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.
In this role, you will perform and manages all types of audits in the clinical studies audit program. It also includes the auditing schedule of clinical investigator sites (phases I to IV), GCP internal systems.
In this role, the selected candidate will assist with development of global GMP policies, standards and procedures for data governance and data integrity in compliance with current and HealthCare Client Authority requirements and industry best practices.
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.
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.
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.