(Associate) Production Manager - ShiP

Job description

The Position

Primary Purpose of Job

• Responsible for producing innovative oral-solid medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Managing operates production equipment for Xeloda/Cellcept that may include process monitoring, sampling, environment monitoring and semi-manufactures transfer operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP), Roche PQS, Standard Operating Procedures (SOP). Responsible for being proficient in functional areas and applies expert knowledge of mechanical, scientific principles, processes and pharmaceutical processing equipment.

Supplementary Responsibilities

• Lead manufacturing to implement cGMP in order to guarantee the quality of products and performance according to Roche standards. By reinforcing and monitoring obedience to national and company’s regulation or policy.
• Working with MSAT closely to prepare solutions for the production process, and continues operational improvement.
• Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.
• Understand the theory, concepts, and regulations behind pharm technology and processes. And Provide strong knowledge of manufacturing department with an understanding of E2E process impact.
• Anticipates potential problems and takes preventative action. Requires judgment to know when it is necessary to consult with support groups.
• Trouble shooting for process problems. Understands how own actions impact others and uses this information in decision-making.
• Review documentation and check all calculations.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation. Exhibit detail oriented documentation skills.
• Cooperate with Technical support team Operate automated systems for equipment operation. Assemble and prepare equipment for production.
• Set up professional interpersonal team. Communicate effectively and ability to work in a team environment.
• Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
• Provide coaching and training on best practices and compliance to SOPs.
• Participate in the respective projects.  
• Participate in and support the projects including but not limited to IQ, OQ, PQ, etc. with high independency and competence.
• Execute the projects and implement the projects.
• Related SAP, MES and Cornerstone system operation.

Education/Qualifications

• Bachelor or above
• Pharmaceutical technology or relevant fields

Leadership Competencies

• Models Integrity
• Focus on value and customer 
• Align for success 
• Deliver results 
• Learn for the future 

Job Required Competencies

• 5 years’ experience in Pharmaceutical industry
• 3 years’ experience in pharmaceutical manufacturing.
• Excellent oral and written communication skills.
• Capable of writing detailed reports and summaries.
• Must possess high level of automation and technical process knowledge as related to prep and process within area of responsibility.
• Familiarity of computer-based systems.
• Strong ability in organization and coordination
• Strong sense of GMP
• Good team management skill
• Language skills – English & Chinese

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 China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.

Roche is an Equal Opportunity Employer.