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Specialist, Quality Operations

3-5 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

Specialist, Quality Operations

Location: India
Job ID: REQ-10026565
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time

About the Role

The Specialist, Quality Operations manages quality-related aspects and projects within their scope of responsibility, ensuring compliance with GxP standards and adherence to the Novartis Quality Management System (QMS).

Key Responsibilities

  • Subject Matter Expertise:

    • Act as a QA Technical SME for CSV processes, including MESKNEAT, and DCS systems.
    • Provide oversight for GMP enterprise systemsmanufacturing systemscomputerized laboratory equipment, and validation software tools.
  • MES Qualification:

    • Oversee and support qualification activities such as URSIQOQ, and other validation protocols.
    • Review and approve QA records, including SOPs, site deviations, CAPAs, and change control documents related to MES projects.
  • Technical Expertise:

    • Hands-on experience with MESKNEATDCSAgile, and 1QEM systems.
    • Ensure accuracy, attention to detail, and adherence to deadlines in quality management processes.
  • Team Collaboration:

    • Lead cross-functional teams within a matrix organizational structure to resolve challenges and implement solutions effectively.

Essential Requirements

  • Experience:

    • 3-5 years of quality assurance experience in GMP environments within the pharmaceutical/biotech industry is preferred.
  • Education:

    • Bachelor’s degree in a scientific discipline (e.g., pharmacy, chemistry, engineering, life sciences) is required.
    • Advanced degree in natural or applied sciences is preferred.
  • Skills:

    • Strong problem-solving and analytical skills with a reliable and accountable work ethic.
    • Proficient computer skills and fluency in English are essential.
    • Excellent time management, planning, and organizational abilities.

Why Novartis?

At Novartis, breakthroughs in healthcare come from fostering collaboration, inspiration, and innovation. Be part of a team that’s creating a brighter future for patients and families.

Benefits and Rewards

Explore how Novartis supports personal and professional growth through its comprehensive Benefits and Rewards HandbookBenefits & Rewards Handbook.

Join the Novartis Network

Stay connected with career opportunities by joining the Novartis Talent NetworkNovartis Talent Network.