▷ (3 Days Left) Team Member - Clinical Dqa (developmental Quality Assurance)

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 a dedicated individual to join our Clinical Quality Assurance team In this role you will be responsible for reviewing and revising Standard Operating Procedures SOPs auditing Bioavailability and Bioequivalence BA BE studies and conducting risk assessments for Vendors Contract Research Organizations CROs Roles Responsibilities Plan perform and document vendor qualification or re-qualification for Clinical CROs clinical sites and other appropriate vendors Conduct comprehensive risk assessments for these entities to ensure compliance with regulatory standards and company policies Lead and execute audits of Central Labs and Bioanalytical components as per the established audit program Conduct both off-site and on-site post-study audits of Bioequivalence studies for Global Clinical Management GCM Global Generic Initiatives GGI Medical Affairs Clinical Research and Russia Clinical Research teams Perform self-inspections of the Global Clinical Management team and GGI Medical Affairs clinical research team to ensure adherence to internal procedures and regulatory requirements Review regulatory deficiency responses and support cross-functional teams in preparing comprehensive and timely responses to regulatory inquiries Provide expert support in the preparation hosting and follow-up of audits from Regulatory Agencies for Clinical Trials and Bioequivalence studies Develop and implement audit responses corrective actions and preventive actions to address observations Monitor and regularly update the Quality Management System QMS for Global Clinical Management and GGI Medical Affairs Clinical Research Ensure the QMS remains current with evolving regulatory requirements and industry best practices Develop review and approve SOPs for pre-clinical clinical and Developmental Quality Assurance DQA processes Ensure these SOPs are aligned with current regulations and organizational needs Collaborate with cross-functional teams to implement quality improvement initiatives and best practices across clinical research operations Provide training and guidance to clinical research staff on quality assurance principles GCP guidelines and regulatory requirements Participate in the development and implementation of data integrity assurance programs for clinical trials and bioequivalence studies Assist in the creation and maintenance of quality metrics and key performance indicators KPIs for clinical quality assurance activities Stay current with evolving regulations and guidelines in clinical research and quality assurance and implement necessary changes in organizational processes and procedures Contribute to the development of quality assurance strategies aligned with the organization s goals and regulatory compliance requirements Represent the Clinical Quality Assurance team in cross-functional meetings and provide expert input on quality-related matters in clinical research projects Mentor junior team members and contribute to the overall professional development of the Clinical Quality Assurance team Qualifications Qualifications Bachelor s degree in Pharmacy Pharmaceutical Sciences or related field MSc in Clinical Research or Master in Pharmacy preferred 3-5 years of experience in pharmaceutical industry focusing on Bioanalytical Method development or Bioanalytical part audit of BE studies Proficient in GCP and GLP Principles with thorough understanding of regulatory requirements in Clinical Research Strong technical skills including SOP management data integrity assurance and adaptability to regulatory changes Excellent communication skills and meticulous attention to detail 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