Team Member - Clinical DQA (Developmental Quality Assurance)

Job Summary

We are looking for a dedicated individual to join our Clinical Quality Assurance 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 organizations 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 :

Additional Information :

About the Department

Global Manufacturing Organisation (GMO)

At Dr. Reddys 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 1150 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. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type : Full-time

Key Skills

Invoicing,Flight Operations,Asset,Geography,Jboss,Accident Investigation

Experience : years

Vacancy : 1