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Analyst – Quality Operations

7+ years
Not Disclosed
10 Nov. 28, 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

Job Title: Analyst – Quality Operations
Job ID: REQ-10030263
Location: Hyderabad, India


Job Summary

As an Analyst in Quality Operations, you will provide quality services in line with cGMP requirements and the Novartis Quality Management System. This role is crucial for ensuring product quality compliance and supporting regulatory workflows in a collaborative environment with business partners.


Key Responsibilities

Quality Operations Services

  • Perform Quality Operations services to support product quality compliance and regulatory workflows.
  • Manage accounts in workflow applications (e.g., SAP, Dragon, SUBWAY) to ensure service deliverables are executed correctly.

Stability & QC Support

  • Assist with stability management, including drafting reports and performing temperature excursion assessments (TEA) and transport risk assessments (TRA).
  • Support QC release activities by creating, modifying, and reviewing inspection plans, lot numbers, certificates of analysis, and specifications.

Monograph & Risk Evaluation Management

  • Author testing monographs and perform impact assessments for testing procedures.
  • Author risk evaluation reports for Nitrosamines, handling both Step-1 & Step-2 evaluations, and managing country-specific risk reports.

Statistical & Business Support

  • Provide statistical support, performance trending, and business support.
  • Ensure compliance with internal quality standards, regulatory requirements, and service level agreements.
  • Support during internal and external audits.

Compliance & Continuous Improvement

  • Comply with GxP policies and Novartis’ internal operating procedures, such as time tracking, KPI reporting, and ticket management.
  • Actively contribute to continuous improvement projects.

Key Performance Indicators (KPIs)

  • On-time and GMP-compliant release of dosage forms.
  • No complaints regarding inspections from authorities in your area of responsibility.
  • Successful support of continuous improvement initiatives.

Minimum Requirements

  • Education: Pharmacy/Science/MBA/Engineering or equivalent from a reputable institute.

  • Experience: At least 3 years in Quality Assurance, Regulatory, or pharmaceutical drug substance/products/medical device manufacturing.

  • Skills:

    • Knowledge of GxP, Quality Assurance, and Quality Control (QC) procedures.
    • Basic IT proficiency.
    • Strong communication, presentation, and interpersonal skills.
    • Ability to work closely with global stakeholders.
  • Languages: Fluent in English (written and spoken).


Why Novartis?

At Novartis, we believe in reimagining medicine to improve and extend lives. Join a community of passionate professionals dedicated to creating breakthroughs that change patients' lives.

What We Offer:

  • A collaborative, supportive, and inspiring work culture.
  • Comprehensive benefits and rewards to help you thrive personally and professionally. Learn more.

Diversity & Inclusion

Novartis is committed to fostering an inclusive environment and building diverse teams that reflect the communities we serve.

Accessibility & Accommodations

If you require accommodations due to a disability, please email us at diversityandincl.india@novartis.com.


Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Location: Hyderabad, India
Company/Legal Entity: Novartis Healthcare Private Limited
Job Type: Full-time (Regular)
Shift Work: No


Ready to join us? Apply now to make an impact in Quality Operations at Novartis!