Associate MSAT Manager - Product Care Expert

Job description

The Position

• Feasibility Study
• Scientific and Technical support for manufacturing
• Investigation/ Troubleshooting /CAPA participation
• Qualification& Validation activities
• Production process analysis
• Product knowledge transfer
• Continuous Improvement and Innovation
• Safety, Health & Environment

• Ability to interpret and apply understanding of the management team’s thinking to projects and apply strategies to the different needs of different product categories. 
• Conduct feasibility study for new product as needed.
• Function as a process and technology subject matter expert, provide on-the-floor and on-site technical support, and perform process monitoring, deviation investigation, troubleshooting, investigation-driven events, and problem solving. 
• Interface to both internal and external SMES, to ensure the dynamic scientific and technical support for RDSZ. 

• Support for the investigation for issues with the corporation with different functions.
• Ensures progress to plan on all project activities including communications, escalations, risk assessment and mitigation and reporting in appropriate systems.
• CAPA management to ensure the sustainable of issue solving.
• Participate in investigation as needed and ensure the whole process are compliance and stick to regulations
• Maintain the network and relationship with internal and external SME to ensure the investigation knowledge attainable and dynamic.
• Execute the rolling out the CAPA lesson and learn in other corresponding site to prevent the issues already fixed in other function not reoccur in RDSZ.

• Participate in project activities and training in order to ensure needed competences for taking the role as particular Subject Matter Expert.
• Participant into implement continuous improvement projects and activities to generates tangible contributions to site operational performance 
• Monitor implementation of Hand in Hand tech transfer process from R&D and/or other site to RDSZ and track performance
• Product trend analysis for commercial products and process monitoring.
• Support  to train the sites for product robustness analysis using statistical tools
• Support second sourcing initiatives to ensure a robust supply chain for critical raw materials. 

• Providing technical support to the transfer team at RDSZ 
• Providing technical support for completion of receiving unit technology transfer deliverables (including: engineering design, construction, commissioning and qualification, validation, translation of process requirements into manufacturing instructions, development of manufacturing instructions, and process performance metrics reporting). 
• Collaborate with validation team and functional SMEs to provide suggestion on pre-validation / validation strategy including process, cleaning, and other supportive studies. 

Qualifications

• Bachelor Degree in Pharmaceutical Engineering, Chemistry or Biology or equivalency. Preferred: Master Degree in Pharmaceutical Engineering, Chemistry or Biology or equivalency.
• Good command of written and spoken English
• At least 7 years in a highly regulated cGMP manufacturing environment or equivalency & have technical support working experience
• Related work experience in the Diagnostics, Pharmaceutical Industry with the field of technical support, QC, validation and R&D related or equivalency
• Solid understanding of the QC/QM/Regulatory process
• Strong team oriented
• High level attention to detail and strong analytical skills 
• Flexible and able to prioritize own work
• Ability to work across functions within the organization/project
• A “can-do” attitude and willingness to go the extra mile when required
• Intercultural understanding and ability to work effectively with other nationalities
• Achieving Results
• Strong technical acumen
• Strong communication and coordination skills 
• Strong continuous improvement expertise
• Superior problem-solving skills with proven ability to anticipate issues and recommend effective and efficient solutions

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.