Lead - Site Investigation Team (sit)

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 For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity - to strengthen our core further the next steps and to build the future the new bets The Next and the New is how we aim to continue to be the partner of choice - purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose - helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparency Dr Reddy s maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization 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 level 2 3 incidents valid OOS Out of specification cases and other relevant incidents 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 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