Location: Suzhou, China
Position Type: Fixed-Term
岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Responsible as internal point of reference to guaranty the new products/processes transfer to production, to provide technical support and /or improvement to existing products/processes, and to participate in change control process for manufacturing.
主要职责 / MAIN ACCOUNTABILITIES
Provide technical expertise for new product transfer for site production activities, change control to existing products/processes and troubleshooting; including scale-up and/or automating production processes in order to increase capacity or reduce production costs;
Analytical methodology study for product transfer project including biochemistry analysis method, Microbiological analysis method, and cleaning residue limit study.
Investigate failures on existing and/or new products and/or processes (including QC processes). Recommend and monitor the implementation of preventive actions and process improvements resulting from these failure investigations;
Create and present reports on conducted experiments, product transfer and validation lots, failure investigations and troubleshooting. Create and revise the necessary documentation to implement into production, including SAP data. Assure the documentation is compliant to company and Regulatory guidelines;
Participate in Project Meeting to present reports and the status of the work package he/she is responsible for;
Use knowledge of techniques and methods such as Project Management, Risk Analysis (e.g. FMEA), Problem Solving Methods (e.g. Lean 6 Sigma);
Coordinate parallel projects involving other departments and assure effective communication;
知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
1.BS with a > 5 years’ experience or MS with > 3 years’ experience in Industrialization /Manufacturing , with pharmaceutical or IVD R&D background will be preferred.
2.Knowledge of Risk Analysis, Problem Solving, current Good Manufacturing Practices, statistical methods, Analytical skills
3.Knowledge of site product lines and manufacturing processes including QC is preferred
4.Knowledge of microorganism subculture, inoculation, identification, and strain features will be preferred.