Summary
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data, coordinating the team/lab under its responsibility. Communicating with internal & external partners for the Quality Control organization. Supports site as technical expert in related field
About The Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
