Senior Expert - QC

Key Responsibilities:

• Act as SME in the area of equipment calibration and qualification in the QC laboratory ensuring compliance with local and global procedures while minimising the impact on the business
• Coach trainers to ensure effective training of QA/QC analysts in area of laboratory equipment and qualification by developing and advising standardized content, materials and assessment tools.
• Act as SPOC for major QC equipment projects and liaise closely with end users and other departments in relation to cross-functional projects
• Management of QC investment budget/QC asset management and utilisation/QC CapEx projects.
• Troubleshoot and resolve challenging issues relating to modifications of current quality compliance processes and systems within and across various functions to ensure all health, safety or training procedures meet requirements.
• Lead cross functional project teams to drive team results including Lab Excellence projects
• Initiate and supervise the Strive to constantly continuous improvement of systems and practices on site with respect to achieve compliance, reducing waste and improving efficiencies
• Stand in for other team members in the QC Support Services team in their absence.

Essential Requirement:

• BS: 6+ years related experience with 3+ years in management
• Related experience should be in GMP-regulated industries in Quality Control.
• Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems.
• Must have an understanding of pharmaceutical industry trends and practices.
• Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.

Desirable Requirement:

• English fluent in speaking and writing. Mandarin Chinese a plus