The Supervisor, Quality Assurance (Compliance and Quality Systems) leads a team of Quality Specialists in daily support of Warehouse, Production, Documentation and Disposition systems through audit and approval of supporting documentation including but not limited to investigation reports, change controls and lot specific product records. Responsible for Quality Assurance oversight of GMP documentation to assure compliance to FDA Outsourcing facility and GMP requirements as well as applicable Fagron Sterile Services requirements. Proactively lead quality system enhancement projects assigned. Work in partnership with production, warehouse, quality control, validation, maintenance and support areas to solve problems and provide expertise on compliance issues and site/corporate policy requirements. Responsible for the development and management of direct reports and supervising the activities of QA personnel primarily supporting Manufacturing and Disposition, ensuring accurate and timely completion of documentation.
- Responsible for administration of Compounding Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time.
- Supervise daily activities of QA personnel, supporting Manufacturing, Documentation, and Disposition. Assure job objectives are met on a timely basis.
- Perform and oversee the training of personnel. Effectively develop, counsel, manage and motivate staff. Write and administer performance appraisals for department personnel.
- Review and approve SOPs and assure SOPs define the steps necessary to complete tasks.
- Ensure team provides adequate and timely quality review support of Warehouse and Production documentation and complete Disposition of incoming and finished products to meet site and customer needs.
- Provide support to associated department management to ensure appropriate corrective action is completed for documentation issues.
- Review deviations and investigations as required. Ensure corrective action is appropriately determined and implemented.
- Initiate/support management meetings/projects to develop and maintain a quality system to facilitate timely product disposition.
- Support the site’s management review/monthly trending program e.g., compile data and complete analysis, prepare summary and provide required information to Management.
- Develop and lead an internal assessment program and support corporate and external agency audits and inspections.
- Support validation, research and development, maintenance and quality control areas in Quality assurance review or decisions when requested by management.
- Perform supplemental investigations/projects as required by management.
- Maintain knowledge of current GMPs and regulatory guidelines.
- Independently and proactively seek new information to assure current status with compliance and regulatory issues through evaluation of available documentation, e.g. other company’s 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, etc.
- Other duties as assigned.
- Bachelor’s degree in science or technical field or equivalent combination of education and experience.
- 5+ years of progressive responsibility in quality to support pharmaceutical manufacturing processes.
- Working knowledge of cGMP and GLP practices. Working knowledge of FDA trends and guidelines.
- Must be able to understand and significantly interpret data utilizing analytical skills and practical experience in pharmaceutical application.
- Demonstrate leadership qualities. Supervisory experience preferred.
- Understanding that error in analysis, judgment or decision making could result in serious implications including Regulatory issues, product recall, product liability and potential patient safety issues.
- Computer skills required.
- Excellent verbal and written communication skills required.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.