For almost 50 years, we have led the way in delivering better clinical evidence with our clinical research data management services. In that time, our technology, expertise and know-how have helped more than 800 new drugs come to market.
Post : Sr Document & Training Compliance Specialist
Job Description
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.
• 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.
Candidate Profile
• Bachelor Degree or equivocal experience required.
• 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.
Additional Information
Experience : 2-3 years
Qualification : Bachelor Degree
Location : India Remote
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th May 2024
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