Quality Assurance Director
3 weeks ago
Job Type: Full-time
Description
Position SummaryThe 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, requiring 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 drive continuous improvement initiatives and be capable of assessing and improving existing systems.
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 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, escalate issues, and drive 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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