Our client is an innovative pharmaceutical company focused on developing and commercializing innovative treatments to meet unmet medical needs. They are committed to improving patient outcomes through continuous research and development, as well as maintaining high standards of quality and regulatory compliance.
Key Responsibilities:
- Drug Development: Collaborate with various teams to enhance or create new drug delivery methods and packaging, including products for clinical trials.
- Manufacturing Process Optimization: Work with CMOs to refine and sustain manufacturing processes, ensuring they meet international standards.
- Quality Assurance: Establish and implement quality control protocols to ensure product standards.
- Regulatory Compliance: Keep abreast of pharmaceutical regulations and ensure all processes and products comply.
- Validation Processes: Create and carry out validation protocols for manufacturing processes, equipment, and facilities.
- R&D: Contribute to research and development, focusing on assay development and data analysis.
- Quality Issue Resolution: Collaborate with QA to investigate product complaints, determine root causes, and implement solutions.
Requirements:
- Bachelor's or higher degree in pharmaceutical/chemical engineering.
- 5+ years of experience in pharmaceutical manufacturing or process development.
- In-depth knowledge of pharmaceutical regulations, quality management systems, and validation processes.
- Skilled in data analysis and statistical tools.
- Experience with health authority inspections/audits and regulatory submissions.
- Proficiency in English and Mandarin.
