Team Member - SIT (Injectables)

About Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories Ltd. is a major multinational pharmaceutical company with over 24,000 employees worldwide dedicated to advancing affordable and innovative healthcare solutions. Founded in 1984 with 20 employees, the company now operates in 66 countries with research, manufacturing, and commercial presence. Dr. Reddy’s promotes values of access, innovation, sustainability, and corporate integrity, aiming to reach over 1.5 billion patients globally by 2030. The company champions equal opportunity employment and fosters a diverse and inclusive work environment.

Job Overview

The SIT Team Member will lead investigations on Out of Specification (OOS), Out of Trend (OOT), deviations, and market complaints. This role involves collaborating closely with cross-functional teams to determine root causes and develop corrective and preventative measures, ensuring thorough documentation and regulatory compliance.

Primary Responsibilities

• Manage investigations related to OOS, OOT, deviations, and market complaints, coordinating with cross-functional teams to identify root causes and establish corrective and preventive actions.
• Review investigation reports critically and offer constructive feedback to enhance quality.
• Monitor and analyze notification trends, highlight key findings or escalate significant issues.
• Conduct ongoing reviews to ensure proper data classification and utilize standardized templates for preparing thorough investigation reports.
• Provide support during regulatory inspections in relation to investigation activities.

Required Qualifications and Experience

• A Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.
• 5 to 10 years of experience within pharmaceutical or allied industries focusing on investigations and quality assurance.

Technical and Behavioral Skills

• Expertise in conducting and managing investigations including root cause analysis and implementing corrective and preventive actions.
• Proficiency in handling valid OOS cases and familiarity with SAP incident logs and data classification.
• Strong report writing capabilities to document investigation findings comprehensively.
• Knowledge of regulatory standards governing incident investigations and ability to support compliance initiatives.
• Collaborative approach with cross-functional teams, strong analytical thinking, detail orientation, effective communication, problem-solving skills, and commitment to regulatory compliance.

Additional Details

Department:
Part of the Global Manufacturing Organisation (GMO), Dr. Reddy’s operates multiple advanced manufacturing units including 3 injectable production facilities. The company emphasizes operational excellence, digitalization, and sustainability as essential pillars of their manufacturing strategy.

Benefits:
Employees receive comprehensive benefits on par with industry standards including relocation assistance, family support programs such as maternity and paternity leave, medical coverage for employees and dependents, life insurance, and personalized professional development initiatives.

Work Environment:
A culture rooted in empathy, dynamism, teamwork, and shared purpose, striving to empower people and foster innovation in healthcare.