Description
Job Description:
Supports quality compliance systems and objectives within the division. Maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This position will interact with cross-functional groups such as Quality Control, Regulatory Affairs and Production.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Ensure approved quality systems are established and maintained. Manage, lead and report on FDA and regulatory compliance inspections. Assist with developing remediation efforts and FDA response when necessary. Maintains and/or monitors compliance tracking systems and archive records, eg document control, deviation reporting, calibration, records retention, records destruct, etc. Understands and follows GMP/GLP/GCP regulations Coordinates and investigates customer complaints Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc. Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects. Performs technical reviews and approves validation documents, design review, engineering reviews, IQ/OQ/PQ, quality reports, protocols, final reports and miscellaneous project documentation. Provides compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation. QUALIFICATIONS:
Excellent attention to detail and strong time management skills Ability to work independently and with work teams Strong technical writing skills Ability to manage multiple tasks and projects simultaneously Develop quality systems and procedures to fit within existing system or create new systems Understands laboratory and manufacturing operations and scientific processes to enable system and documentation audits. Proven understanding and accomplishment in development and deployment of divisional quality systems associated training and roll out. Proven understanding of CAPA systems, training, and document control requirements. Ability to negotiate, troubleshoot, assess and remediate. Proven Ability to provide Quality guidance, recommendations, decisions, and feedback to the Analytical, Engineering, Manufacturing, Quality, and Regulatory teams. These are critical to the success of the business and to ensuring compliance and acceptable standards throughout all aspects of the company's business practices. The impact of such guidance, decisions, and recommendations can have a direct effect on the company's ability to develop new products and manufacture/produce existing products. Proven Ability to analyze and interpret data to utilize such data to make data driven decisions when providing guidance and recommendations. Provide guidance with respect to quality analysis and guidance for the decision making process associated with the contract manufacturers. Ability to prioritize work, goals and tasks per the divisional and corporate objectives. Ability to communicate within all areas of AHD to facilitate audits, trainings, compliance and support corporate objectives Ability to develop, conduct/direct and report audits, trainings, projects, and investigations in support of production, laboratory, contractors or other Alpharma groups. -PC literate with the following applications: MS Excel, Word, PowerPoint. EDUCATION and/or EXPERIENCE:
Qualified candidates will have a Bachelor's Degree in a scientific field. A minimum 10 years scientific field preferably in a FDA regulated industry. The position requires approximately 20% domestic travel. Must possess strong oral and written communication skills and the ability to work independently. Penicillin Allergy Testing is required prior to start.
SKILLS
MS Excel, MS Outlook, MS PowerPoint, MS Word, FDA Regulations, Regulatory Documentation, Good Laboratory Practices (GLP), Good Manufacturing Practices
Synectics is an Equal Opportunity Employer.
