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Manager QA Operations
4 months ago
Essential Duties and Responsibilities
: Provide leadership, direction, and support to the people within the Quality Assurance Operations department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner. Maintain current knowledge of regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site. Ensure procedural documents, manufacturing batch records and process within the manufacturing operations are in accordance with FDA regulations and GMPs. Responsible for approving raw materials, excipients, APIs and components material qualifications. Responsible for ensuring that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labelling and drug products are released in accordance with the registered specifications. Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions. Responsible for labeling processes and management. Responsible for disposition of drug products. Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. Participate or lead in quality risk analysis process transfers. Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions. Promote a quality mindset and quality excellence approach to all activities. Promote a safety mindset and focus on safety for all operations activities. Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.Minimum Qualifications (Knowledge, Skills, and Abilities)
8+ years experience working directly with manufacturing in the sterile injectable pharmaceutical and packaging operations. Bachelor-level or higher education. Project management, organization, and execution skills are required. Ability to apply technical expertise to solve problems and issues. Experience with technology transfers and new product introduction. Knowledge of data integrity controls in a manufacturing setting. Participation and leading activities to support regulatory agency inspections required. Minimum of 3 years experience in a supervisory role. Excellent interpersonal and written communication skills and experience using various software/electronic applications required. Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment. Ability to work autonomously and within established guidelines, procedures, and practices. Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters. Continuously looking for opportunities to learn, build skills and share knowledge with others.Preferred Qualifications:
Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired. Experience with isolator technology. Experience with combination products.