Job Description:
- Manage the Production team and plan the resources to meet customer needs for the production of Reagent. Report to Production Manager of the Project.
- Possess experience in NPI activites ( transfer from Lab to production )
- Work with PPIC ( Production Planning and Inventory Control ) team to develop and implement procedures for the efficient production of Reagent, develops and administers process control programs to ensure acceptable production standards.
- Manage Facility team to upkeep building facilities and infrastructure equipment through ad hoc repair, periodic maintenance, upgrading and replacement schedule.
- Work with Production and PPIC and team to identify areas for improvement in production process for current products
- Work with QA, QC, PPIC to identify and resolved production related problems. Work with SCM ( Supply Chain Management ) to meet customer fulfilment.
- Work with R&D & Purchasing team to evaluate alternate raw materials and/or alternate vendors when necessary
- Providing measures on CAPA issues to achieve acceptable quality standards
- Ensures all production groups are in compliance with the quality requirements and ISO 13485.
- Ensures a smooth transfer of new product from R&D to production. Provides management and technical support to project team.
- Support NPI Manager to prepare yearly budget reports. Controls projects undertaken so that they are completed on schedule and within budget.
- Participates as a Production Management representative at the Biosafety and General Safety Committee and assists in the overall safety program for all employees in meeting safety standards.
Requirements/Qualifications:
- Candidate must possess at least Bachelor's Degree/Post Graduate Diploma/Professional Degree, Master's Degree in Engineering (Bioengineering/Biomedical), Engineering (Chemical), Biology, BioTechnology, Science & Technology or equivalent.
- At least 3 Year(s) of working experience in the related field is required for this position.
- Preferably senior Engineer or Assistant Manager who specialized in Manufacturing/Production Operations or equivalent.
- Knowledge in InVitro Diagnostic Device / Biomedical reagent production will be desirable
- Experience in converting / transferring the product from R&D to production will be desirable.
- Relevant experiences in resource planning, production, process and facility management.
- Problem solving skills
- Good communication skills
- Good knowledge with procedures in production processes, manufacturing practices, Biological Agents and Toxin Act will be advantageous