Manager, Quality Assurance
Overview
Kashiv Pharma, LLC. is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.
The Quality Assurance Manager is responsible for maintenance of Kashiv Pharma’s quality management system, batch record review and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.
Responsibilities
Key responsibilities of the position include, but are not limited to –
Develop, initiate, manage and implement improvements to quality systems and processes.
Ensure that all operations are compliant with cGMPs regulatory requirements.
Write, review and approve SOP system documents to ensure cGMP compliance, as required.
Review and approve raw materials and components, manufacturing documents, including standard formula, test analyses, batch production records and batch packaging records for release.
Review and approve quality control documents, including quality specifications and testing standards.
Oversee the storage of retained samples and batch documentations.
Develop and report on Quality Metrix
Develop and implement vendor / supplier managerial program.
Conduct qualification audits on vendor / supplier.
Participate in deviations and OOS result investigations.
Ensure proper root-cause analysis and implement corrective and preventive actions.
Planning and implementation of Quality Review Board meetings.
Interface with all levels of Kashiv team to resolve issues.
Support development/projects, as needed.
Requirements:
Qualifications
Bachelor (required) /Master degree in Life Science or other related discipline. Minimum of 6 years relevant experience in a pharmaceutical quality assurance/control environment.
Experience of GMP document review, Quality Management System maintenance, quality auditing.
Understand the requirements and procedures related to document control and Quality Assurance.
