Job Responsibilities

• Develop Manufacturing / Operating Instructions and necessary Standard Operating Procedures.
• Develop, maintain, review and troubleshoot the process control system recipe / models.
• Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review.
• Develop, implement and monitor robust preventive measures for processing issues.
• Lead/ part of cross functional team for product transfer of new product on site and interface with above site and transferring sites to ensure flawless transfer of product to site.
• Able to carry out technical and/or GMP assessment for evaluation of processes.
• Lead/ part of team for product/ process transfer between the different process centric team
• Monitor, identify, develop and implement improvements in processes and equipment.
• Provide operating instruction and process training to different audiences such as operations, process team, quality operations and engineering.
• Own one or more multiple equipment / GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
• Ensure adherence to approved procedures and update procedures as required, including the principles and practices of good data management (ALCOA)
• Focus on Safety and GMP Compliance as operational priorities and as performance measures.
• Accountable for the Good Data Management and Data integrity understanding and performance.
• Report and investigate actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.

Job Requirements:

• Bachelor's Degree, preferably in Chemical Engineering or degree in science with a major in Chemistry
• At least 5 years' experience in pharmaceutical (API), with relevant manufacturing environment for senior position
• Experience in providing technical solutions for complex problems through equipment and process understanding
• Working knowledge of Food and Drug Administration Regulations, and Good Manufacturing Practices
• Experience in automation including DeltaV and equipment validation would be a plus
• Proactive, has experience with high-performance teams, good interpersonal and project management skills

Teh Hui Tian, Zoe EA License No. 02C3423 Personnel Registration No. R2089915

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