Quality Assurance Manager
4 weeks ago
Job Summary
The Quality Assurance Manager at Kashiv BioSciences LLC is responsible for maintaining the company's quality management system. This role oversees and directs the activities of the QA organization, ensuring compliance with cGMPs and regulatory requirements. The ideal candidate will have a thorough knowledge of laboratory practices, including testing and OOS investigations, and QMS systems such as Deviations, CAPAs, and Change Controls.
Key Responsibilities
- Oversee thorough and compliant investigations, including Deviations and CAPAs.
- Develop, initiate, manage, and implement improvements to quality systems and processes.
- Ensure all operations are compliant with cGMPs and regulatory requirements.
- Write, review, and approve SOP system documents to ensure cGMP compliance, as required.
- Oversee review and approval of raw materials and components, manufacturing documents, including standard formula, test analyses, batch production records, and batch packaging records for release.
- Oversee review and approval of quality control documents, including quality specifications and testing standards.
- Supervise and direct the activities of QA staff.
- Monitor the 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 vendors/suppliers.
- Participate in deviations and OOS result investigations.
- Ensure proper root-cause analysis and implement corrective and preventive actions.
- Plan and implement Quality Review Board meetings.
- Interface with all levels of the Kashiv team to resolve issues.
- Perform other functions as required or assigned.
- Comply 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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