Specialist – Quality Operations

3+ years

Not Disclosed

Hyderabad

10 March 4, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/B.E./B.Tech/MBA 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
Job ID: REQ-10019221
Location: Hyderabad, India

Summary:

The Specialist – Quality Operations ensures compliance with cGMP requirements and Novartis Quality Management System (QMS) while managing quality aspects and projects within their area of responsibility.

Key Responsibilities:

Coordinate and manage analytical method transfers and stability studies, including data compilation.
Oversee the life-cycle management of analytical methods, ensuring compliance with pharmacopoeia and regulatory requirements.
Handle deviations, investigations, OOS/OOE/OOT cases, changes, and complaints.
Perform statistical data analysis to report Out of Expectations (OOE) and Out of Trends (OOT).
Maintain SAP master data, create Q-info records, and perform related SAP activities.
Validate spreadsheets and compile data from various repositories (SAP, LIMS, external COAs).
Author, approve, and archive impurity risk assessments (Nitrosamines, residual solvents, etc.).
Monitor, trend, and report all QMS elements and Health Safety and Environmental parameters.
Ensure GMP compliance through document compilation and review, including analytical protocols, annual performance quality reports, ongoing process verification reports, and registration documents.
Perform Quality Control activities as per site requirements.
Support regulatory requirements by handling routine queries and chromatogram requests.
Compile Quality performance management decks.
Create and review GxP documents, including SOPs, trend reports, qualification reports, and technical investigations.

Essential Requirements:

Education: Pharmacy/Science/MBA/Engineering or equivalent from a reputed institute.
Experience: Minimum 3 years in Quality Assurance, Regulatory, or pharmaceutical manufacturing.
Skills:
- Strong GxP knowledge.
- Basic IT proficiency.
- Good communication, presentation, and interpersonal skills.
- Experience in working with global stakeholders.

Why Novartis?

Novartis is committed to reimagining medicine and improving lives through innovation. We foster an inclusive work environment and provide rewarding career opportunities.

Learn more: Novartis People & Culture
Benefits & Rewards: Novartis Life Handbook

How to Apply:

Join us in shaping the future of medicine! Apply now or connect with our talent network:
Novartis Talent Network

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Specialist – Quality Operations

Job Description

Summary:

Key Responsibilities:

Essential Requirements:

Why Novartis?

How to Apply:

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