US-NJ-Swedesboro: QA RA Manager

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 06-Apr-2009

QA/RA Manager

Essential Functions:

§ Ensures all phases of compounding, packaging and formulation development comply with relevant SOPs and GCPs (Good Compounding Practices) and safety guidelines.

§ Abides by and promotes quality achievement and performance improvement throughout the organization to ensure regulatory compliance to various industry organizations.

§ Ensures that the Quality Management System is established, implemented and maintains its effectiveness in accordance with applicable standards. Revises, reviews and assists in the development of SOP’s and monitors adherence to these through regularly scheduled audits.

§ Tracks and trends customer complaints, quality related investigations and provides technical assistance required to implement Corrective and Preventative Action (CAPA) to completion.

§ Proposes process improvements to strengthen systems and prevent quality/regulatory related issues.

§ Assists in the development and execution of quality systems that measure progress against quality objectives and reports on various compliance metrics.

§ Creates, organizes and maintains regulatory documents and correspondence and ensures timely, accurate and suitable submission to various regulatory authorities.

§ Responds to all requests for regulatory information and assists in coordination of regulatory agency meetings and preparation of materials.

§ Acts as liaison between Regulatory Affairs, lobbyists, public affairs, and various industry organizations. Reviews and analyzes documentation generated by Research and Development, Sales and Marketing, or other departments. Provides advice as to acceptability of the regulatory strategy presented.

§ Maintains audit-readiness at all times and provides support during any regulatory inspections.

§ Constantly monitors regulatory environment by reviewing technical publications, articles and abstracts to maintain current regulatory knowledge and trends.

§ Works with management to develop appropriate regulatory strategies. Communicates effectively and efficiently with all levels of personnel both internal and external (i.e. pharmacists, technicians, suppliers, representatives from various regulatory bodies, etc.)

Required Credentials:

§ Bachelor of Science degree in a scientific discipline.

§ Minimum of 5 years of experience in Quality Assurance/Regulatory Affairs with direct experience in the pharmaceutical, chemical, food or related industry.

§ Demonstrated ability to communicate and work effectively as a team member and colleague with other areas in the organization to assist with resolution of quality matters.

§ Must have excellent written, verbal communication and presentation skills with the ability to communicate clearly, succinctly and effectively.

§ Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.

§ Comfortable with minimal supervision while maintaining good communication.

§ Strong analytical abilities coupled with creative problem solving skills.

§ Must be able to work in a fast-paced and timeline-driven environment.

§ Proficient with Microsoft Office software and working knowledge of document management systems and quality systems, e.g., GXPs, United States Pharmacopoeia (USP).

§ Experience in delivering training programs related to quality and other regulatory requirements.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com