Given the importance of Quality in everything we do—from manufacturing to laboratory work to inspections- there are many facets within the moniker itself, including:
- Supply Chain Quality Assurance
- DEA Operations
- FDA Inspections and Interactions
Most facets are separate entities under Quality, with a person heading the respective team. The groups break down as follows:
- Quality Assurance
- Specialist for Standard Operating Procedures
Aurobindo Pharma USA (Aurobindo) employees believe quality is not only Quality’s responsibility, but also it’s a belief that is pervasive throughout the enterprise. ‘quality is everyone’s responsibility.’ Moreover, beyond just a mind-set is the fact that the talented associates practice what they believe. For example, processes and systems developed outside of the quality discipline build in the same kind of robust system to produce a safe and effective product.
Their objective– Instill a quality culture within the many companies that make up the Aurobindo family. One of the aspects characterizing the culture is the importance of building in improvement metrics for goals such as compliance. Sustaining compliance, too, is critical. Therefore, Aurobindo fosters an environment of individual and group responsibility, ensuring people take personal ownership.
Training, too, is imperative in order to both instill the total quality management in its current team and also with on-boarding new associates. With Aurobindo’s extraordinary growth over the last decade, there are many new employees being added in order to handle the increased workload. Yet, Quality insists on the continuous training of processes (SOPs) and programs in order to ensure people are knowledgeable, empowered to make certain levels of decisions, and accountable for their actions. This ‘can-do/will-do’ mentality along with a team concept helps Aurobindo build in the quality it needs to succeed in a regulated environment.