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Specialist-Quality Operations

1+ years
Not Disclosed
0 March 4, 2025
Job Description
Job Type: Full Time Education: M.Pharm/ MBA / B.tech / B.E. 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: Hyderabad, India
Category: Quality
Business Unit: Innovative Medicines
Job Type: Full-time, Regular
Company: Novartis Healthcare Private Limited

Main Purpose of Role:

  • Provide quality services in compliance with cGMP requirements and the Novartis Quality Management System.
  • Ensure adherence to regulatory workflows and product quality compliance.

Key Responsibilities:

Quality Operations Services:

  • Execute quality operations services to maintain product compliance and regulatory adherence.
  • Manage accounts in workflow applications (e.g., SAP, Dragon, SUBWAY).
  • Generate and analyze reports from applications like AGILE PLM, AQWA.
  • Escalate GxP and non-GxP issues, ensuring timely investigations.
  • Ensure compliance with Novartis internal quality standards, regulatory requirements, and service level agreements.
  • Participate in internal and external audits, ensuring compliance and process improvement.

Annual Product Quality Review (APQR):

  • Extract and compile product quality data from Novartis systems.
  • Prepare external supplier APQRs and interpret findings.
  • Coordinate with CMOs and manufacturing sites for required data.
  • Maintain and update APQR schedules and ensure timely completion.
  • Archive approved APQR reports and update data in e-compass files.

Marketing Authorization Holder (MAH) Review:

  • Support the maintenance of MAH/BRS review schedules.
  • Coordinate with internal stakeholders for data collection.
  • Compile and interpret regulatory compliance data into predefined templates.
  • Ensure accuracy and completeness of MAH/BRS reviews before submission.
  • Archive approved MAH/BRS review documents for record-keeping.

Key Performance Indicators:

  • Timely completion of APQRs and MAH reviews.
  • Accuracy in data extraction, compilation, and interpretation.
  • Compliance with regulatory requirements and GxP standards.
  • Effective participation in audits and quality investigations.

Qualifications:

  • Education: M.Pharm/ MBA/ Engineering or equivalent from a reputed institute.
  • Experience: Minimum 1 year in Quality Assurance, Regulatory Affairs, or Manufacturing of pharmaceutical products/medical devices.
  • Skills:
    • Basic understanding of GxP compliance.
    • Strong analytical and quality management skills.
    • Experience with SAP, AQWA, AGILE PLM is a plus.