GMP Deputy Manager / Senior Specialist

About the role

Roche is hiring a GMP Deputy Manager or GMP Senior Specialist in Shanghai to support the production department with GMP compliance, training, deviation handling and audit readiness. The role acts as the main link between production and QA/Compliance on GMP matters.

Key responsibilities

• Work with cross-functional teams to implement GMP systems, processes and workflows for production
• Develop and run GMP training programmes for production staff, aligned with corporate quality policy and regulatory requirements
• Set up deviation management and CAPA processes, and implement a change control process with proper documentation
• Support facility qualification audits and regulatory inspections, and act as the production department's liaison during internal and external audits
• Manage ongoing GMP training, investigate and resolve deviations, and evaluate and document changes in production
• Lead consumable material and service introductions and support GMP documentation such as SOPs and validation protocols

Required profile

• Bachelor's degree or above; pharmaceutical or biological background preferred
• 5+ years of GMP compliance experience in the injection pharmaceutical industry; MNC biopharma preferred
• Experience in facility design, commissioning and qualification projects preferred
• Fluent English communication skills preferred

Required skills

• Strong knowledge of cGMP and pharmaceutical regulations, especially in the biological industry
• Hands-on experience with deviation handling, CAPA management, change control and audit preparation
• Familiarity with compliance tools and systems for training, deviations and CAPAs