Sr Document
2 weeks ago
Promote interdepartmental collaboration by partnering with departments to facilitate corporate compliance objectives related to document management and training compliance.Lead initiatives that support the team's ability to deliver high quality systems, execute efficient processes, and develop appropriate tools that will enhance team performance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead departmental efforts related to systems, processes, or tools to enhance team performance and maximize the ability to better serve the organization. Develop interdepartmental relationships to support departments and achieve corporate compliance measures. Maintain the company's departmental training programs and the company's training documentation records through the administration of Clario's Quality Management System, in accordance with standard operating procedures. Document and maintain current training programs for all department positions per the direction of department management. Ensure that all training records submitted are complete and accurate. Administer the Quality Management System application to: Maintain an up-to-date user list. Track employee required training. Issue training activities to employees according to their company position and associated training requirements. Run reports to monitor employee training deficiencies. Enter training dates for instructor led / classroom type training. Manage all employee CVs and Signature Logs according to standard operating procedures and make them available upon request. Maintain the company's quality system documents through the administration of the Quality Management System, in accordance with standard operating procedures. Ensure that all quality system documents are maintained in compliance with regulatory authorities and internal standards and can be efficiently retrieved in the event of an audit. Implement procedures to ensure consistent maintenance of all quality system documents held in the Quality Management System. Maintain systems to accurately track and retrieve documents upon request. Perform reviews of quality system documents for completeness and formatting accuracy. Administer the document management system application to: Provide regular compliance and SOP status reports. Run reports to monitor review schedules. Provide documentation of review according to standard operating procedures. Coordinate the archiving of quality system documents as required. Provide appropriate Quality Management System Document and Training Management training for company personnel. Serve as local on-site support for organizational document and training compliance needs. Develop and execute strategies to promote excellent customer service.OTHER DUTIES AND RESPONSIBILITIES:
Support the implementation of new/revised data systems, technologies, and methods to improve Clario services or support Operation expansion. This includes: Participating in systems implementation teams. Establishing User Requirements. Conducting test scripts and ad hoc testing. Creating system SOPs and developing manuals and training materials. Completing all necessary training and competency testing. Assist departments, when requested, with collection, organization and management of documentation to support the QA department.QUALIFICATIONS AND SKILLS NEEDED:
Education:
Bachelor Degree or equivocal experience required.Experience:
2-3 years of related business experience in document and training management activities within a Quality Management System or equivalent. 2-3 years of experience in pharmaceutical field (or related industry experience). Knowledge of the pharmaceutical drug development process and CPMP guidelines. General knowledge of pharmaceutical regulatory practices as they pertain to use of electronic data collection and results reporting. Excellent communication, customer service, problem solving, and organizational skills. Ability to lead and influence without direct authority.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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