lavori da Operation Manager in località United States

The Operations Lead will be based in Midrand and responsible for ensuring the optimum utilization of all laboratory resources, quality, and timely results for customers.

The incumbent will play a key role in securing the technical competency and relevance within the company across current and future analytical fields, as part of its strategic planning. They will oversee all aspects of day-to-day laboratory operations, ensuring accurate and timely results while maintaining a safe and efficient work environment.

The Operations Lead ensures the company's competitive positioning as an independent analytical laboratory to meet client needs in accordance with the South African Health Products Regulatory Authority (SAHPRA) and international standards. This role covers all operations, including insourced and outsourced activities.

1. Enforce company policies and standard operating procedures in collaboration with the QA Manager.
2. Manage the analytical laboratory in compliance with cGXP standards, adhering to SAHPRA guidelines and regulations.
3. Promote quality and regulatory compliance, ensuring accuracy and thoroughness in all functions.
4. Verify and process supplier documents and maintain approved supplier databases.
5. Draft and compile reports, verify results, perform calculations, and sign off raw data.
6. Ensure data integrity in line with ALCOA standards.
7. Collaborate with the People, Culture and Purpose Manager on all People and Culture matters, including leave management.
8. Participate in recruiting qualified team members.
9. Assist with performance management to foster a high-performance culture.
10. Promote a culture of 'right first time' and continuous improvement.
11. Build, influence, and inspire the team to create an equitable environment conducive to growth.
12. Manage subcontracted projects and outsourced services, including qualification of service providers and suppliers as per SOPs.
13. Implement and maintain apparatus maintenance programs, report issues, and coordinate repairs.
14. Oversee laboratory equipment performance, establish quality standards, develop SOPs, and ensure staff compliance.
15. Coordinate calibration schedules and maintenance of laboratory apparatus.
16. Oversee day-to-day operations, including health and safety compliance, security, and project management.
17. Supervise access control and project execution in collaboration with relevant managers.
18. Manage waste according to SOPs and oversee stability programs.
19. Control and supervise confidential information and documentation.

• Bachelor's Degree in Pharmaceuticals or Chemistry.
• Minimum 10 years of laboratory experience.
• At least 5 years of experience as a Laboratory / Operations Lead.
• Experience in technical document compilation, document control, and data integrity.

• Excellent computer skills, especially in MS Office.
• Strong understanding of business principles.
• Knowledge of cGxP regulations and regulatory requirements.