Production Manager – System Reagents

Job description

The Position

Job Summary

Routine operation management to ensure the safe, reliable, cost-effective, and efficient production of the product portfolio for system reagents and on-time delivery according to the production plan. Provide leadership and ensure development, compliance and maintenance of qualified personnel within the routine operational team.

Main Tasks & Responsibilities

1. Responsible for the management of GMP manufacturing operations and the personnel for the production of the system reagents.

2. Define adequate staffing and skill levels and corresponding training matrix, and ensure the conduct of the trainings accordingly.

3. Lead the team to achieve team targets, and participate in all aspects of staff management (interviewing, training, coaching and developing). 4. Monitor work to ensure quality, and continuously promote Quality First Time and aim to continuously improve the efficiency of manufacturing operations.

5. Write and revise batch records, SOPs and solution preparation documents to ensure compliance to GMPs.

6. Review and approve inventory count plan in order to find out the variance against the standards.

7. Review workshop's Process Order (PO) and then pass to Finance for further analysis in order to balance all resources for production.

8. Schedule manufacturing staff to ensure manufacturing timelines are met.

9. Provide cross-functional coordination and issue resolution.

10. Planning & Budgeting.

11. Involve in technical product transfer project working with Germany and US sister sites to ensure all manufacturing related technical knowledge and documentation have been transferred safely and effectively which comply with the regulatory requirements and the Quality Management System process.

12. Other ad hoc tasks.

Qualification & Experience

• Bachelors Degree in Manufacturing, Electrical, Automation or Mechanical Engineering; (preferred MedTech) or equivalent by experience
• 8 years’ experience in a highly regulated cGMP manufacturing environment
• At least 2-3 years’experience in SAP
• Knowledge of TPM (total productive maintenance) is recommended Solid experience in project management

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.