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Team Member - Qa (Investigation)

2+ years
Not Disclosed
10 Aug. 21, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 prominent multinational pharmaceutical company with a global presence. Our mission is to accelerate access to affordable and innovative medicines, guided by our belief that Good Health Can’t Wait. Founded in 1984 with a small team and a bold vision, we have since expanded to over 24,000 employees across 66 countries.

Our commitment to access, affordability, and innovation is rooted in deep scientific expertise, progressive practices, and strong corporate governance. As the pharmaceutical industry evolves, we focus on strengthening our core operations and exploring new opportunities, guided by our principle of "The Next and the New." Our goal is to reach over 1.5 billion patients worldwide by 2030, with sustainability integrated into our core strategy. We operate in a manner that respects people, the planet, and our purpose, ensuring resource conservation, stakeholder value, and integrity.

Dr. Reddy’s is an equal opportunity employer, committed to fostering a diverse workforce. We value merit and diversity, ensuring that all qualified individuals have the opportunity to succeed.

Job Title: Quality Assurance Specialist

Job Summary

We are seeking a Quality Assurance Specialist to join our team, focusing on the investigation of manufacturing, quality control, and engineering incidents. This role involves ensuring compliance with quality standards and overseeing Quality Management System (QMS) activities.

Roles & Responsibilities

  • Investigate manufacturing process, quality control, and engineering incidents or deviations.
  • Prepare investigations for market complaints.
  • Conduct audits and ensure compliance in manufacturing, engineering, and quality control areas.
  • Oversee all Quality Management System (QMS) related activities.

Qualifications

  • Educational Qualification: Bachelor’s degree in Pharmacy, MSc in Chemistry, MSc in Microbiology, Chemical Engineering, or a related field.
  • Experience: 3 to 7 years of experience in pharmaceutical manufacturing or a similar role.

Skills & Attributes

  • Technical Skills:

    • Knowledge of microbiology, aseptic practices, cleaning validation, sampling, and relevant standards.
    • Proficiency in line clearance, material verification, start-up checks, and in-process checks in accordance with batch manufacturing and packing records.
    • Experience in sampling and testing of in-process, reserve, finished, stability, and environmental samples.
    • Skilled in reviewing and certifying batch manufacturing and packing records.
  • Behavioral Skills:

    • Attention to detail in performing line clearance, verification, and record reviews.
    • Effective time management and coordination for sampling, testing, and batch activities.
    • Strong communication skills for interacting with team members and stakeholders.
    • Problem-solving abilities for addressing issues related to line clearance, sampling, and records.
    • Commitment to high-quality standards and regulatory compliance.

Additional Information

About the Department: The Global Manufacturing Organisation (GMO) at Dr. Reddy's Laboratories is dedicated to global healthcare through precision manufacturing and innovation. We operate 19 advanced manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, including facilities for oral solid doses (OSD), injectables, and active pharmaceutical ingredients (API). Our commitment to operational excellence and continuous improvement drives us to deliver high-quality medicines globally. We focus on productivity enhancement and digitalization to meet our ambitious environmental, social, and governance (ESG) goals and build the "factories of the future."

Benefits Offered: Dr. Reddy’s provides competitive benefits, including personalized learning programs, relocation support, family support (maternity and paternity benefits), medical and life coverage, and other essential benefits.

Our Work Culture: At Dr. Reddy’s, our guiding principle is "Good Health Can’t Wait," reflecting our commitment to improving lives through healthcare solutions. We foster a culture of empathy and dynamism, supporting individual abilities while promoting teamwork and shared success. We believe that diverse skills and a common purpose drive our ability to make a significant impact.

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