Product responsibilities:
1.1. Maintain overall performance to deliver product in consistently quality.
- Realised the variance target by optimizing process and receipt to improve yield and better product economy.
- As product owner, maintain and update product matrix, PMD, Master data and BoM of the responsible product.
- Follow and review batch performance and product quality to support batch release.
- Lead and support the troubleshooting of process and equipment to maintain the functionality and enhance the reliability on top of operation simplification.
- Lead or support deviation investigation for root cause analysis and CAPA (Corrective Action and Preventive Action) execution
1.2. To be captain anchoring new product introduction
- Lead and coordinate all stakeholders for new product introduction checklist
- Process mapping for gap close
- Raw material mapping for gap close
- Master data and BOM establishment
- Lead the execution and reporting of engineering runs and PQ campaign.
2. Drive or deeply involved in CAPEX Project
- User manager or representative of CAPEX project by cooperation with project manager
- Lead the user group to initiate and update URS
- Review and approve design package
- Lead or coordinate the qualification tasks (DQ/FAT/SAT/PQ) to deliver the project meeting URS requirements.
- Prepare and submit the qualification protocol and report.
- Coordinate and support punch list close.
- Lead or support minor IA execution.
3. Equipment technology
- Support on equipment trouble shooting together with R&M and production team.
- Responsible to liberate capacity via equipment optimization.
4. Support to business stakeholders
- Process training to operation teams.
- Other relevant training according to compliance requirements or predefined training plan.
- Support internal and external audit.
- Lead or support the closing of relevant audit observations.
5. Other duties
- Perform other duties as assigned by the Operations Director.
Competencies Required:
- Competence of user manager or representative for CAPEX project.
- Mindset of dare to lead and strong execution ability.
- Strong ability to work collaboratively in a team-based environment.
- Be able to take fast and effective operation related decisions.
- Strong ability to work in an effective and flexible way.
Qualifications, Skills and Experience:
- Minimum master’s degree in Biotechnology / Biochemical / Biopharma manufacturing
- Minimum of 5 years of relevant experience in positions.
- Knowledge and practice related with environment, safety and compliance regulations etc.
- Knowledge and familiarity with GMP, food safety and hygiene etc.
- Strong communication skills in both English and Chinese.