Lead Associate, Quality Audits

Job Summary

We are looking for a seasoned Lead Associate Quality Audits professional who will conduct assessment on company sites internal GMP (Good Manufacturing Practices) departments external partners and quality systems for ensuring compliance with regulatory requirements and expectations standards industry trends and regulatory commitments as well per company policies and procedures. The role involves supporting readiness for regulatory inspection and collaborating across the regional organization to participate in cGMP (current GMP) and GDP (Good Distribution Practice) compliance initiatives and continuous improvement. The role will report to Lead Quality & Compliance.

Roles & Responsibilities

• You will be responsible for maintaining and enhancing the Supplier management process using quantitative methods to identify high-risk suppliers.
• You will be responsible for conducting detailed assessments of manufacturing processes quality control procedures and documentation systems to ensure compliance with established standards.
• You will be responsible for identifying areas for process improvement and recommending corrective actions to enhance efficiency and quality outcomes.
• You will be responsible for conducting audits of external suppliers and vendors to assess their adherence to quality standards.
• You will be responsible for preparing comprehensive audit reports detailing findings observations and recommendations for improvement.
• You will be responsible for driving the implementation of quality improvement initiatives based on audit findings and industry advancements.
• You will be responsible for conducting thorough assessments of potential vendors quality systems capabilities and processes to ensure alignment with organizational quality standards.
• You will be responsible for planning and executing audits of vendors quality management systems manufacturing processes and facilities to ensure compliance with relevant regulations and industry standards.
• You will be responsible for regular monitoring and analyzing vendor performance data to identify trends and potential issues.
• You will be responsible for communicating quality expectations and vendor-related updates to internal stakeholders ensuring alignment and understanding across the organization.
• You will be responsible for maintaining Regional Supplier Qualification Reports and Audit Reports. You will prepare and manage Approved Vendors.
• You will be responsible for supporting regulatory compliance oversight of Dr. Reddys North America business and identifying areas for correction to eliminate compliance gaps.
• You will be responsible for proactive research of new and upcoming regulations and guidelines.
• You will be responsible for supporting the Regional Quality Council coordinating compliance metrics for North America and providing periodic updates to Executive Management.
• You will prepare revise and execute quality agreements with all vendors in the quality system.
• You may be required to travel domestically and internationally.

Qualifications :

Educational qualification : M.S. in Chemistry Biology or other life sciences; Auditing Certification preferred

Minimum work experience : 8 years of progressive experience in auditing pharmaceutical or medical device systems including 2 years of internal and external audit management experience

Skills & attributes :

Additional Information :

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion age sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against based on disability.

For more details please visit our career website at Work :

No

Employment Type : Full-time

Key Skills

Distribution,IT,Access Control System,B2C,Courier Delivery,Broadcast

Experience : years

Vacancy : 1