Team Member - Clinical DQA (Developmental Quality Assurance)

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