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Quality Assurance
The Corporate Quality Assurance Unit is an independent organizational group in Advinus, reporting directly to the CEO & Managing Director. It is primarily responsible for:
- Quality Assurance functions in GLP and GMP areas in the development center
- Adopting Tata Business Excellence Model (TBEM) in the company
QA functions
- Assure that studies are performed in compliance with the principles of GLP or products are synthesized / prepared in compliance with cGMP requirements
- Conduct inspections/audits – study based, facility based and process based, including systems, test sites, and contract test facility.
- Review SOPs, protocols/study plans, draft and final reports
- Issue audit/inspection reports, QA statements to GLP reports, and release products as per GMP, as applicable.
- Coordinate inspections/audits by Monitoring and Regulatory authorities as well as by clients.
Tata Business Excellence Model (TBEM)
- A quality system for systematically pursuing global levels of business performance by adopting the principles of TBEM, which is based on the Baldrige National Quality Award program.
- A desire to leverage through Tata group’s Brand Equity and Business Promotion, a commitment to run the Business Excellently & Ethically.
- Adopts the Tata group’s five core values underpinning the way we do business: Integrity, Understanding, Excellence, Unity, and Responsibility.
- Leverages on the Performance Excellence Framework, viz., Leadership; Strategic planning; Customer and market focus; Measurement, Analysis and knowledge management; Workforce focus; Process Management, and Business results for continuous improvement and Organizational performance excellence.
