Clinical Quality Assurance Associate

4 weeks ago

Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time

Job Summary

We are seeking a highly skilled Clinical Quality Assurance Associate to join our team at Dr. Reddy's Laboratories Limited. As a Clinical Quality Assurance Associate, you will be responsible for developing and maintaining training matrices for each job role in clinical development, ensuring all referenced SOPs and guidance are current and accurate.

Key Responsibilities

  • Develop and maintain training matrices for each job role in clinical development in consultation with Functional Heads/Leads.
  • Circulate updated training matrices, harmonize and incorporate any changes requested by Functional Heads/Leads.
  • Track and coordinate training for new hires, internal promotions, and employee re-joining after long leave.
  • Prepare training materials and conduct classroom trainings on SOP/regulatory guidance/QMS documents/eClinical Tools.
  • Create training courses in Learning Management Systems (LMS) and assign the courses to relevant job roles. Track and ensure employees are compliant with training needs and escalate non-compliances to Functional Heads/Leads.
  • Assist in the development of new training tools and learning initiatives.
  • Assist in revising cross-functional documentation and training materials when a process is updated or developed.
  • Participate in process improvement initiatives and collect appropriate metrics and provide periodic scheduled reports on progress against process improvement objectives.
  • Manage archives, coordinate with Biologics archival teams for Sponsor documents, and coordinate with third-party archival service providers (Vendors) for investigator site-specific documents.
  • Review and approve invoices generated by archival vendors.

Qualifications

Any Life Science graduate.

About the Department

Biologics currently operates in the Global Biosimilars business, a segment poised for attractive and sustained growth over the next 10-15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales, the future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing, and commercializing multiple biosimilar products.

Benefits Offered

At Dr. Reddy's, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy's are on par with the best industry standards, including joining and relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself.

Our Work Culture

At Dr. Reddy's, we see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives. We foster a culture of empathy and dynamism, where people are at the core of our journey. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

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