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Msat Specialist

6-8 years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/PhD 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 Name: Dr. Reddy’s Laboratories Ltd.
Location: India (Integrated Product Development Organisation)
Date: Immediate


Company Overview

Dr. Reddy’s Laboratories Ltd. is a global leader in the pharmaceutical industry, committed to making healthcare accessible and affordable. Since its inception in 1984, the company has expanded to 66 countries, with over 24,000 employees working toward one common goal: "Good Health Can’t Wait." Dr. Reddy’s aims to reach over 1.5 billion patients by 2030, focusing on sustainability, innovation, and building the future of healthcare. The company fosters an inclusive work environment, valuing diversity and merit in all employees.


Job Title: Technology Transfer Specialist

Department: Integrated Product Development Organisation
Location: India


Job Summary

Dr. Reddy’s is looking for a Technology Transfer Specialist to support the development and implementation of robust manufacturing processes. This includes authoring validation protocols and reports, conducting risk assessments, and using advanced tools for process monitoring. The role involves active participation in technology transfers, continuous improvement initiatives, and ensuring compliance with regulatory requirements in manufacturing operations.


Key Responsibilities

  • Validation:

    • Preparation, review, and approval of Master Production Records (MPR).
    • Authoring, reviewing, and approving process validation protocols.
    • Preparing, reviewing, and compiling validation reports.
  • Technology Transfer:

    • Coordinate with vendors and cross-functional teams for technology transfer activities.
    • Execute technology transfer processes at receiving units.
  • Quality Improvement Plans (QIP):

    • Identify root causes for QIPs and execute corrective actions.
    • Provide conclusions and recommendations for QIP issues.
  • Out-of-Specification (OOS)/Out-of-Trend (OOT) Investigation:

    • Investigate root causes for OOS/OOT occurrences.
    • Implement corrective actions and ensure compliance with protocols.
  • Compliance and Coordination:

    • Ensure that validations are carried out per protocol, meeting cGMP and regulatory standards.
    • Coordinate with cross-functional teams for validation execution.
    • Participate in internal and external audits and present documents to auditors and inspection teams.

Qualifications

  • Education: Masters/Bachelors/Ph.D. in Pharma.
  • Experience: 6-8 years of experience in process development, MSAT, or technology transfer in the pharmaceutical industry.

Skills & Attributes

Technical Skills:

  • Expertise in scale-up/technology transfer of products, particularly in relevant dosage forms or technologies (e.g., OSD).
  • Proficiency in process engineering, Quality by Design (QbD) principles, and risk assessment methods.
  • Knowledge of International Council for Harmonization (ICH) guidelines related to product and process development.

Behavioral Skills:

  • Ability to work in cross-functional teams and interact with multiple stakeholders.
  • Strong analytical and problem-solving abilities to address process and quality challenges.

About the Department: Integrated Product Development Organisation

The Integrated Product Development Organisation at Dr. Reddy’s combines cutting-edge science and technology to create innovative, affordable therapies for patients worldwide. The department covers end-to-end capabilities across Active Pharmaceutical Ingredients (API), formulations, clinical research, intellectual property, and regulatory affairs. Dr. Reddy’s serves more than 55 markets globally, offering a broad portfolio of generic and innovative products, including oral and injectable formulations. The department has filed over 1,000 patents and publishes extensively in peer-reviewed journals.


Why Join Dr. Reddy’s?

At Dr. Reddy’s, you will be part of a dynamic and innovative team focused on improving global healthcare. With the opportunity for continuous learning and growth, the company provides a supportive environment where your contributions will directly impact the health of patients around the world.

For more details and to apply, visit: Dr. Reddy's Careers.


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