Manager Quality Assurence

Responsible for planning and implementing the activities of Quality Assurance to ensure the achievement of projects and goals. Monitors and evaluates completion of tasks and projects. May develop budgets for capital expenditures and labor. Typically participates with other managers to establish company policies. Serves as a project champion in areas of expertise. Position requires minimal guidance and direction. Assure that all areas of the PuraCap facility comply with current Good Manufacturing Practices and that any deviations observed are documented and corrected. Define and implement Quality Assurance objectives and strategies. Supervise and direct the development and administration of budgets, schedules, and resource allocation. Audit and evaluate vendors/suppliers/CMOs in the US and overseas. Assist the Quality Director in writing and preparing quality and manufacturing SOPs and related documents. Assure that all PuraCap products are manufactured and packaged in full compliance with FDA regulations, current industry standards, current Good Manufacturing Practices (GMP), and PuraCap SOPs. Investigate actual and potential manufacturing packaging problems and provide documented results to the Director of Quality. Provide supervision and training to all Quality Assurance department personnel. Assure that the requirements of the Master Validation Plan (MVP) are followed by production personnel and that the MVP is reviewed on a bi-annual basis. Assure that all vendors used by PuraCap have been appropriately audited and/or approved by Quality Assurance. Review batch records to ensure correctness, completeness, and cGMP compliance.

Job Specification

5-7+ years experience in QA or similar function within a pharmaceutical environment (substantial pharmaceutical QC experience will be a plus). A high level of competence in the day-to-day management of the QA program. Performed audits and inspections of studies, programs, processes, and/or quality systems of CMOs to ensure compliance with cGMP regulations, FDA guidelines, and industry standards. Worked towards or participated in the development and implementation of QA programs. Excellent writing skills required for preparation of regulatory and quality documents. Familiarity with QC operations is a plus. #J-18808-Ljbffr Management & Operations