Instagram
youtube
Facebook

Msat Specialist

6-8 years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./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 Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company committed to improving global healthcare by providing affordable and innovative medicines. With over 24,000 employees across various global locations, Dr. Reddy's mission is to accelerate access to medicines that meet the evolving needs of patients worldwide.

Founded in 1984, the company started with a small team and a vision to revolutionize healthcare. Over the years, Dr. Reddy’s has expanded its footprint and now operates in 66 countries with R&D centers, manufacturing facilities, and commercial presence. The company emphasizes sustainability, focusing on people, planet, and purpose as part of its growth strategy, aiming to reach over 1.5 billion patients by 2030.

Dr. Reddy’s fosters an inclusive work environment that values diversity, merit, and equal opportunity for all employees.


Job Description

Position: Technology Transfer Team Member

Dr. Reddy’s is looking for a Technology Transfer Team Member to play a key role in the development and implementation of robust manufacturing processes. This position involves authoring validation protocols, conducting risk assessments, and supporting technology transfer activities. The role will also focus on continuous improvement initiatives and ensuring compliance with regulatory requirements across manufacturing operations.

Roles & Responsibilities:

  • Validation:
    • Prepare, review, and approve Manufacturing Process Records (MPR), process validation protocols, and validation reports.
    • Ensure that validations meet cGMP and regulatory requirements.
  • Technology Transfer:
    • Coordinate with vendors and cross-functional teams for technology transfer activities.
    • Execute technology transfer of products at receiving units.
  • Quality Improvement Plans (QIP):
    • Identify the root cause of Quality Improvement Plans (QIP) and execute necessary actions.
    • Provide conclusions and recommendations for improvement.
  • Out of Specification (OOS)/Out of Trend (OOT) Investigation:
    • Investigate OOS/OOT occurrences and determine the most probable root causes.
  • Cross-functional Coordination:
    • Collaborate with cross-functional teams for the execution of validations and technology transfer activities.
    • Participate in monthly reporting, internal and external audits, and assist in presenting documentation to auditors/inspection teams.

Qualifications:

  • Educational Qualification: Master’s, Bachelor’s, or Ph.D. in Pharmaceutical Sciences or related field.

  • Minimum Experience: 6-8 years of experience in Process Development, MSAT (Manufacturing Science & Technology), or Technology Transfer.

Skills & Attributes:

  • Technical Skills:
    • Experience in scale-up and technology transfer of products, especially in Oral Solid Dosage (OSD) forms.
    • Familiarity with Process Engineering, Quality by Design (QbD) principles, and risk assessment approaches.
    • Knowledge of International Council for Harmonization (ICH) guidelines related to product and process development.

About the Department

The Integrated Product Development Organization at Dr. Reddy's blends deep scientific expertise with cutting-edge technology to develop accessible and affordable healthcare solutions. The team works across various stages of product development, including API, formulations, clinical trials, intellectual property, and regulatory affairs.

Dr. Reddy's has a global presence in over 55 markets and offers a wide range of innovative and generic products, including oral formulations, injectables, ophthalmics, and more. With a robust R&D team, the company has filed over 1,071 patents and published over 1,000 research papers for peer review.

For more information, visit Dr. Reddy's Careers.