Responsible for the management of the Manufacturing Quality Assurance departmental activities, which include managing the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product. Responsible for quality assurance oversight of the manufacturing and packaging processes and procedures; which allow for the accurate and timely release of manufacturing and packaging batch record documentation. The MQA Manager provides final review of investigations to ensure product quality, and appropriate implementation of corrective action in a timely manner to prevent recurrence. Performs analysis on quality and manufacturing indicating data and recommends actions for compliance and process improvement.Responsibilities
- Leads team of MQA Supervisors and Specialists in daily integration of monitoring, auditing and review of manufacturing operations.
- Provides compliance direction to all functional groups within manufacturing, Packaging, MQA and other quality support groups.
- Evaluates existing quality systems at the facility. Recommends, develops, secures approval of, implements and follows up on new and existing quality systems.
- Utilizes and updates systems in place to perform per the current processing requirements.
- Designs, implements and monitors performance of daily quality assurance audit function, in-process quality check and batch record review.
- Troubleshoots manufacturing and quality issues. Forms corrective action plans to resolve issues.
- Troubleshoots and monitors performance of quality assurance personnel in the following functions:
- Reviewing production deviations and environmental excursions.
- Assisting in evaluation of action plans.
- Review of protocols for process and equipment enhancements.
- Conducting process audits of the manufacturing areas. Issuing batch records. Performance of labeling and functionality checks Execution of the inspection program, including qualifications, AQL executions and defect categorizations. Auditing completed batch records prior to product release.
- Performing daily quality oversight of production with focus on critical process steps. Trending/analyzing process data. Supports Quality in inspections for the Manufacturing facility.
- Effectively hires, develops, coaches, manages and motivates staff. Supports and implements HR policies and procedures. Writes and administers performance appraisals.
- Identifies and implements needed organizational changes to meet operational plans and assure the attainment of QA goals and objectives. Develops and administers financial budget for the department.
- Manages work in process for the facility to facilitate timely release of finished product which meets Fresenius Kabi and GMP requirements.
- Releases product, which has demonstrated compliance to Fresenius Kabi and GMP requirements through review of manufacturing and testing documentation.
- Assures that product not meeting specifications is properly investigated prior to release and/or rejection.
- Advises the Director, QA on matters relating to daily operations. Makes/implements recommendations for improvement. Prepares reports as required.
- Performs supplemental investigations/projects as required by Senior QA and Operations management.
- Ensure department personnel are aware of Fresenius Kabi’s Environmental and Energy Management System including Environmental and Energy Policy.
- Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System.
- Bachelor of Science Degree required.
- Requires five (5) to seven (7) years of supervisory responsibility in quality to support pharmaceutical manufacturing processes.
- Extensive knowledge of legal and regulatory requirements governing the manufacture of pharmaceutical products.
- Must be able to understand and interpret data utilizing analytical skills and practical experience in pharmaceutical application.
- Demonstrate leadership and decision making qualities.
- Technical knowledge of all manufacturing related processes, process and equipment validation preferred.
- Computer skills required.
- Excellent verbal and written communication skills required.
Fresenius Kabi offers an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
*Must be authorized to work in the United States; the Company will not sponsor work visas or other employment authorization. *