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Specialist - Quality Operations

3+ years
Not Disclosed
10 Sept. 23, 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

Summary

The Specialist in Quality Operations is responsible for managing quality aspects and projects within their area of responsibility, ensuring compliance with GxP standards and adherence to the Novartis Quality Management System.

About the Role

Position: Specialist – Quality Operations
Location: Hyderabad

Key Responsibilities:

  • Coordinate and manage analytical method transfers and stability studies, compiling necessary data reports.
  • Oversee the life-cycle management of analytical methods, ensuring performance control, compliance with pharmacopoeia and health authority standards, and identifying method improvements.
  • Handle deviations, investigations, Out of Specification (OOS), Out of Expectation (OOE), Out of Trend (OOT) cases, as well as changes and complaints.
  • Perform statistical data analysis for reporting OOE, OOT, and related findings.
  • Manage SAP master data, including the creation of Q-info records and other SAP-related activities.
  • Validate spreadsheets and compile data from various repositories (SAP, LIMS, external Certificates of Analysis).
  • Author, approve, and archive impurity risk assessments, including those for nitrosamines and residual solvents.
  • Monitor, trend, and report on Health, Safety, and Environmental parameters.
  • Implement GMP requirements and compile/review documents such as analytical protocols, reports, annual performance quality reports, and registration documents (Common Technical Document modules).
  • Act as a Quality Control expert as defined by site requirements.
  • Support regulatory inquiries and manage requests for chromatograms.
  • Compile quality performance management presentations and reports.
  • Create and review GxP documents, including SOPs, working procedures, trend reports, qualification reports, and technical investigations.

Essential Requirements:

  • Degree in Pharmacy, Science, MBA, Engineering, or a related field from a reputable institution.
  • Minimum of 3 years of experience in Quality Assurance, Regulatory Affairs, or pharmaceutical manufacturing.
  • Knowledge of GxP and basic IT systems.
  • Strong communication, presentation, and interpersonal skills.
  • Experience working with global stakeholders.

Why Novartis?

At Novartis, we are dedicated to reimagining medicine to improve and extend lives. Our vision is to be the most valued and trusted medicines company in the world. Our associates drive our ambition, and we invite you to be part of this mission. Learn more here.

Benefits and Rewards

Discover our comprehensive benefits and rewards in the Novartis Life Handbook here.

Join Our Novartis Network

If this role isn't the perfect fit for you, but you'd like to stay updated on future opportunities, join the Novartis Network here.


At Novartis, we believe that innovative science requires a community of passionate individuals. Together, we can achieve breakthroughs that transform patients' lives. Ready to create a brighter future?