• Development and/ or revision of Master Batch Records (MBRs) and/or Electronic Batch Record (eBR) and other current Good Manufacturing Practice (cGMP) documents e.g. Standard Operating Procedures (SOPs), Work Instructions (WIs) used in the execution of manufacturing processes and/or operations here onsite.
• Performing deviation investigation and documenting the process and the outcome of the investigation. This includes but not limited to root cause analysis, appropriate Corrective and Preventive Actions (CAPAs) definition and product impact assessment.

The individual should work very closely with Subject Matter Experts (SMEs) in Manufacturing Sciences and Technology (MSAT), Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), Validation (VAL), Engineering (ENG) and any other relevant departments. The individual should have good understanding of manufacturing processes, operational knowledge of manufacturing equipment and expected to interact with external customers for presentation of the investigation findings. The individual needs to have strong technical writing skills and excellent oral presentation skills. This position reports to Senior/ Section Lead/ Manager of Manufacturing Support Team

Responsibilities:

• Design and develop new paper record Master Batch Record (MBR), using existing MBR templates, in support of Technology Transfers
• Design and develop new Electronic Batch Record (eBR), utilizing the knowledge of know how to create, test and launch eBR in the system for execution
• Maintain currency of MBRs/eBRs for existing customers
• Write and edit technical information/ instructions in a manner to ensure content is factual and accurate
• Collaborate closely with relevant SMEs from various disciplines on documentation requirements
• Manage the lifecycle of MBRs/eBRs including, but not limited to creation, review, revision and approval of MBRs/eBRs on product campaign basis
• Communicate actively to address customers’ comments and to clarify customers’ queries with respect to MBRs/eBR
• Deliver MBRs/eBRs with strict adherence to the production schedule
• Provide assessments and insights to Change Requests from TWT’s perspective
• Perform detailed and thorough investigation for deviations, non-conformities and/ or abnormalities which occur on production floors
• Involve in the deviation investigation, batch record review and TrackWise documentation. Possess TrackWise Supervisory access
• Ensure timely investigation and closure of all deviation reports in support of lot disposition.
• The completion of a deviation report includes but not limited to root cause analysis utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, Failure Mode, Effect and Cause Analysis (FMECA), product/ quality impact assessment/ justification and design of appropriate CAPA(s) with effectiveness checks, where required
• Lead investigation by facilitating discussions with relevant SMEs from all departments in the course of deviation investigation
• Coordinate and collaborate cross-functionally to achieve completion of an investigation and the design of appropriate CAPA(s)
• Interact with customers in the form of face-to-face meetings and/ or teleconferences to communicate investigation findings/ outcomes to the customer
• Present the output from an investigation in the form of a deviation report and ensure the information populated in the deviation report, in particular the most probable root cause, impacted and associated lots is factual and accurate
• Prepare and own storyboards for identified deviations to facilitate customer and regulatory audits
• Participate in customer and regulatory audits to present and walk auditors through the deviation investigation
• Involve in preparation of deviation metrics, to identify trends and work with Lead/ Manager to put in place measures to improve deviation life cycle, deviations reduction and any other areas of improvement
• Provide continued motivational and team building atmosphere. Assist Manufacturing management in the definition, development and provision of career progression paths for individuals
• Carry out performance reviews and recommend advancements for team members where reasonable
• Responsible for staffing, training and retaining energized, motivated, team oriented staffs
• Responsible for continuous learning, development and advancement of staffs
• Assume accountability on recognition and disciplinary responsibility for all team members
• Any other duties as assigned by your Supervisor/Manager

• BS in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/ Microbiology) related disciplines preferred
• Work experience in a cGMP regulated environment and prior technical knowledge in biopharmaceutical processing will be an advantage
• Strong technical communication and writing skills
• Excellent oral presentation skills
• Exhibit strong command of English and Chinese both in writing and oral.
• Effective interaction skills with MSAT, MFG, QA, VAL, QC, ENG, customers and auditors
• Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint
• Track record in completing projects under tight timelines
• Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts
• Ability to influence peers and teams with no direct reporting lines
  

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