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Team Member - Sit

7–10 years
Preferred by Comapny
11 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company with a presence in 66 countries. Our 24,000+ employees work every day with a shared purpose: to accelerate access to affordable and innovative medicines, guided by our belief that Good Health Can’t Wait.

Founded in 1984 with just 20 employees and a bold vision, we have grown into a global organization with state-of-the-art research and development centers, manufacturing facilities, and commercial offices worldwide. Over the past four decades, we have been committed to access, affordability, and innovation, anchored in deep scientific expertise, progressive people practices, and robust corporate governance.

As the pharmaceutical industry evolves, we embrace opportunities to strengthen our core capabilities and build the future. Our strategy, The Next and the New, aims to sustain our leadership as a purpose-driven, future-ready, and sustainable organization. By 2030, our goal is to impact over 1.5 billion patients worldwide, ensuring sustainability remains integral to our purpose and strategy. This includes respecting people, the planet, and purpose to conserve resources, serve patients, create stakeholder value, and operate with integrity and transparency.

Dr. Reddy’s is an equal-opportunity employer, committed to fostering a diverse and inclusive workplace free from discrimination. We value and nurture talent regardless of race, color, religion, nationality, gender, age, disability, or any other protected characteristics.


Job Description

Job Summary We seek a highly skilled professional to join our Site Investigation Team (SIT). The role involves overseeing deviations, collaborating with Cross-Functional Teams (CFT) to identify root causes, and implementing corrective and preventive actions. The successful candidate will also actively participate in investigating Out of Specification (OOS) and Out of Trend (OOT) cases and provide regulatory inspection support.

Roles & Responsibilities

  • Oversee deviations from inception, collaborating with CFT members to identify root causes, corrective actions (CA), and preventive actions (PA).

  • Actively participate in investigating valid OOS and relevant cases, determine root causes, and craft comprehensive reports.

  • Conduct periodic assessments of deviation trends, escalate key observations, and ensure accurate classification of incidents.

  • Utilize Rubrics templates for detailed investigation reports and provide constructive feedback for improvement.

  • Support site readiness and participate during regulatory inspections related to investigations.

Qualifications

Educational Qualification:

  • Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.

Experience:

  • 7–10 years in the pharmaceutical or related industry with a focus on investigations and quality assurance.

Technical Skills:

  • Expertise in root cause analysis, corrective actions, and preventive actions.

  • In-depth knowledge of OOS investigations and regulatory requirements.

  • Experience in drafting comprehensive investigation reports and supporting regulatory inspections.

Behavioral Skills:

  • Strong analytical and problem-solving skills.

  • Ability to collaborate effectively with diverse teams.

  • Excellent attention to detail and communication skills.

  • Commitment to compliance and readiness for inspections.


About the Department: Global Manufacturing Organisation (GMO)

Dr. Reddy’s Global Manufacturing Organisation is dedicated to making a significant impact on global healthcare through precision manufacturing and innovation. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, including:

  • 8 OSD facilities

  • 3 Injectable facilities

  • 8 API facilities

We are recognized for operational excellence and quality, with our largest facility in Bachupally, Hyderabad, part of the Global Lighthouse Network by the World Economic Forum. Our portfolio includes complex APIs and over 1,150+ drug master files across key therapeutic areas such as oncology, cardiovascular, CNS, and anti-diabetes. Through continuous innovation, digitalization, and sustainability, we aim to build the factories of the future and create healthcare solutions for tomorrow.


Benefits Offered

At Dr. Reddy’s, we prioritize career growth and professional development with personalized learning programs. Our benefits include:

  • Joining and relocation support

  • Family support (maternity and paternity benefits)

  • Comprehensive medical coverage for employees and families

  • Life insurance coverage

  • Continuous learning and development opportunities


Work Culture

At Dr. Reddy’s, our credo, Good Health Can’t Wait, inspires everything we do. Healthcare solutions are not just formulations but a means to empower patients to lead healthier lives. We foster a culture of empathy, innovation, and teamwork. Diversity and collaboration are the cornerstones of our success, and we strive to create an environment where every individual can reach their potential.

For more details, please visit our career website at: Dr. Reddy’s Careers