· Develop Manufacturing / Operating Instructions and necessary Standard Operating Procedures.
· Develop, maintain, review and troubleshoot the process control system recipe / models. Guide process engineer in team for the process control system recipe / models development.
· Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review. Participate or lead quality / safety investigations and implement any corrective and preventive actions from these investigations.
· 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 for the commercial manufacturing and provide technical guidance to the process centric team and/ or operation team during the manufacturing.
· Play a pro-active role and lead changes in ensure the site safety and quality standards are adhered to.
· Proactively monitor, identify, develop and implement improvements in processes and equipment.
· Communicate on a regular basis to the plant personnel and stakeholders on process updates.
· 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.
· Train the process technicians on the process and procedures as required.
· 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.
· Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, QO, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations
REQUIREMENTS
· Bachelor's Degree, preferably in Chemical Engineering or degree in science with major in Chemistry
· At least 5 years' experience in pharmaceutical (API), with relevant manufacturing environment for senior position
Email: [email protected]
Whatsapp: 96503173
Telegram: @jesswongie
Jessie Wong Yuan Si
Personnel EA License No.: R2197171
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
