QA Manager

1 month ago

South Plainfield, United States Kashiv BioSciences LLC Full time

Job Type Full-timeDescriptionPosition Summary The Quality Assurance Manager is responsible for maintenance of Kashiv's quality management system. This role will oversee and direct the activities of the QA organization. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and QMS systems such as Deviations, CAPAs, and Change Controls. This person will be responsible for ensuring that manufacturing operations have appropriate QA oversight, including identification and management of Nonconformance, Investigations, and Deviations. The QA leader will be expected to drive continuous improvement initiatives and be capable of assessing and improving existing systems. A demonstrated ability to successfully mentor staff and collaborate across multiple departments to drive timely resolution of projects, investigations, and process improvements is required. The incumbent will be responsible for all functions of the Quality Assurance team, including providing guidance in support of both late-stage clinical and commercial biosimilar products and small molecule in cGMP-compliant laboratories and the manufacturing operation. Essential Duties & Responsibilities Oversee thorough and compliant investigations, including Deviations and CAPAs. 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.Oversee review and approval raw materials and components, manufacturing documents, including standard formula, test analyses, batch production records and batch packaging records for release.Oversee review and approve quality control documents, including quality specifications and testing standards.Supervises and directs the activities of QA staff.Monitors effectiveness of Quality Systems, developing event metrics such as number and type of batch record errors, training deviations, etc., and trend analysis for management review, escalates issues and drives resolution.Conduct qualification audits on vendor / supplier.Participates 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.Performs other functions as required or assigned.Complies with all company policies and standards. Requirements Bachelor or Master degree in Life Science or other related discipline.Minimum of 10 years of relevant experience in pharmaceutical quality assurance/control environment.Minimum of 3 years in a direct supervisory role.Experience of GMP document review, Quality Management System maintenance, quality auditing.Understand the requirements and procedures related to document control and quality assurance.

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