1.Tell us more about your role at No deviation.
I joined No deviation with a background in process SME, and the company has since helped my development in the domain of Quality and Compliance. I’d very much love to pass on my knowledge, experience and passion to the talent within No deviation and our industry.
2. How would you describe audit and compliance in a few easy-to-understand words?
Compliance with regulatory requirements is mandatory but never the end of our journey. The ultimate goal is always to achieve quality and assure patient safety.
An audit is a great (yet scary) way to identify the gap to compliance or space for improvement. It is driving us to continual improvement.
3. What would you tell a client that has contracted No deviation for an audit and compliance project?
The goal of an audit or GxP remediation project is never to criticise but to work hand-in-hand with our client to analyse the risk, understand the gap, establish expectations and achieve the state of control. Remember, there’s never one solution that fits all.
4. What are the potential challenges you have faced in quality and compliance projects? How did you overcome the difficulties they presented?
The challenge has always been achieving the required state with limited time and resources. Hence, we adopt the ‘Lean Approach’ by categorising issues with various priorities, and provide a short-term fix and long-term remediation on sound science and risk basis. The projects are always rolled out in a ‘stage gate’ manner, hence the work at each stage gate is fit for the intended purpose, with progress assured in the long run.
5. What type of quality and compliance work do you have the greatest passion for?
Anything that requires a fresh perspective and a new area of study. Also, root cause analysis/deviation investigation, which looks at the overall picture and looks into each aspect.
Learn more about our quality and compliance services at No deviation.
With 15 years of experience in the global pharmaceutical industry, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both Consultant and End User roles. With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.