Lead - Site investigation - OSD

Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

Job Description

Job Summary
We are looking for someone to lead investigations into incidents and OOS cases, ensuring thorough root cause analysis and implementation of CAPA, crucial for maintaining product quality and compliance. The role involves reviewing incident reports, collaborating with cross-functional teams, and providing mentorship to enhance investigation and reporting capabilities, ultimately fostering a culture of continuous improvement and regulatory compliance within the organization.
Roles & Responsibilities
• You will be responsible for leading investigations into deviations, OOT, OOS cases, and other relevant quality notifications, collaborating closely with SIT (Special Investigation Team) members, site CFT (Cross-functional Teams), and operating staff to determine root cause, corrective actions (CA), and preventive actions (PA), ensuring unbiased and objective closure with high confidentiality.
• You will review level 1B incidents, provide improvement feedback, and periodically assess level 1A incident trends, highlighting key observations.
• You will review incident-related reports and SAP incident logs, ensuring proper classification and notifying management of findings.
• You will be responsible for using Rubrics template for investigation report writing and provide support to sites during regulatory inspections.
• You will participate in internal/external audits, mentor site investigation team members, and contribute actively to site review meetings.
• You will facilitate the development of site CFT members' investigation and report writing skills, setting up a review and governance mechanism for SIT at the site.
• You will be responsible for presenting periodic updates on key findings, open issues, and learnings to management, fostering strong connections between site leadership, MSAT (Manufacturing Science and Technology) members, and key stakeholders.

Qualifications

Educational qualification: B.Pharm. or M.Pharm.
Minimum work experience: 10 to 15 years

Preferred : Investigation, statistics, with MSAT background , Should have understanding of Manufacturing and analytical.
Skills & attributes:
Technical Skills
• Experience in handling OOS and investigations, root cause analysis, CA and PA.
• Proficiency in leading investigations and applying RCA methodologies to identify underlying causes accurately.
• Experience in utilizing incident management systems like SAP incident logs to track, classify, and manage incidents effectively, ensuring proper documentation and notification of findings to management.
• Understanding of regulatory requirements related to incident investigation and reporting, including familiarity with Rubrics templates for investigation report writing and support during regulatory inspections.
• Experience in participating in internal and external audits, providing support in investigation-related matters, and ensuring compliance with audit requirements and standards.
• Capacity to mentor site investigation team members, facilitate skill development in root cause analysis and report writing, and establish governance mechanisms to ensure the quality and consistency of investigations across the site.
Behavioural skills
• Good writing skills for preparing technical reports.
• Strong collaborative skills to work closely with SIT members, site CFT and management, fostering teamwork.
• Excellent communication skills to convey complex technical information clearly and concisely.
• Demonstrated leadership abilities to lead investigations, mentor team members, and facilitate skill development, inspiring confidence and trust in the investigation process and outcomes.
• Critical thinking and analytical skills to analyse incident-related data, identify patterns and trends, and draw meaningful insights.

Additional Information

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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.
For more details, please visit our career website at https://careers.drreddys.com/#!/