Supervision, coordination, and administration of stability operations, with a strong focus on team management and quality assurance.
Responsibilities
Responsibilities: Reporting to the Managing Director, specific responsibilities include but are not limited to:
Â
Operational Activities:
Oversee the daily operations of stability storage, ensuring that all processes are carried out efficiently and in compliance with regulatory standards.
Manage the receipt, placement, and monitoring of customer product samples, ensuring accurate documentation and adherence to study protocols.
Ensure that all stability operations are conducted in accordance with the company's Quality Management System (QMS) and current Good Manufacturing Practices (cGMP).
Liaise with various departments, including Quality, to ensure seamless integration of stability operations with overall company objectives.
Facilitate communication between team members, external consultants, and contractors to ensure alignment and efficient workflow.
Maintain comprehensive records of all stability operations, including study paperwork, monitoring equipment logs, and QMS documentation.
Ensure that all administrative tasks, such as responding to emails, maintaining invoices, and managing contractor reports, are completed promptly and accurately.
Implement and oversee the use of new equipment and technologies to enhance stability operations.
Team Management:
Lead and manage a team of operational staff, providing guidance, support, and performance feedback to ensure high levels of productivity and morale.
Conduct regular team meetings to discuss progress, address challenges, and plan for future activities.
Develop and implement training programs to enhance team skills and ensure compliance with regulatory standards.
Foster a collaborative and positive work environment that encourages teamwork, innovation, and continuous improvement.
Manage schedules, workloads, and performance for team members.
Quality Assurance:
Oversee all QMS activities, ensuring that stability operations meet the highest quality and compliance standards.
Monitor operations, identifying areas for improvement and implementing corrective and preventive actions (CAPA) as needed.
Drive correct use of quality manuals and continuous improvement initiatives, working closely with management to drive quality improvements.
Ensure that all planned and unplanned changes (deviations) are thoroughly investigated, documented, and addressed.
Support the quality team with internal reviews and audits to ensure ongoing compliance with GMP certification and regulatory requirements.
Qualifications
Third Level Qualification in Science or a related field is desirable but not essential.
Equal employment opportunity, including veterans and individuals with disabilities.
