Quality Assurance Manager
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About The Position
The position requires a detail-oriented individual responsible for ensuring that the drugs manufactured at Washington Homeopathic Products meet prescribed quality levels. The individual will implement quality control programs, prepare quality guidelines for production and quality control of pharmaceuticals, and conduct quarterly audits of processes for conformance to cGMP to detect deficiencies and recommend corrective actions. Additionally, the role involves administratively supervising quality unit staff, keeping records of quality reports, and facilitating proactive solutions by collecting and analyzing quality data. The individual will also audit and certify vendors and suppliers of WHP components, validate Certificates of Analysis, and serve as the primary contact during FDA on-site inspections of the facility. Staying abreast of internal policies and external regulations is crucial, as is preparing and updating quality documentation based on 21 CFR Parts 210 and 211. The position also requires working with the WHP Production Manager to ensure that production employees are aware of quality requirements, providing training in best practices, and promoting a culture of quality within the organization. The individual will review statistical data from production lines to identify quality problems, perform investigations of customer complaints, and develop continuous improvement programs aimed at reducing defects and improving quality levels. Finally, the individual will develop and conduct validations for processes, cleaning, and equipment, oversee the change control program, and perform the final release of finished products, ensuring that documentation is complete and accurate.
