Specialist-Quality Operations

1+ years

Not Disclosed

Hyderabad

10 Jan. 15, 2025

Job Description

Job Type: Full Time Education: M.Pharm/ MBA / B.E./BCS 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-10035539
Location: Hyderabad, Telangana, India
Posted on: January 5, 2025
Employment Type: Full-time, Regular

Role Summary:

The Specialist - Quality Operations provides quality services that comply with cGMP requirements and the Novartis Quality Management System. This role supports product quality compliance and regulatory workflows by ensuring the timely execution of service deliverables and assisting in various quality-related activities within the organization.

Key Responsibilities:

Quality Operations Services:
- Deliver quality operations services in support of product quality compliance and regulatory workflows.
- Ensure execution of service deliverables in systems like SAP, Dragon, and SUBWAY.
Data Reporting & Analysis:
- Generate and analyze predefined and ad-hoc reports in various applications (e.g., AGILE PLM, AQWA).
- Perform follow-up actions on reports and escalate GxP/non-GxP issues for timely investigation.
Quality Compliance:
- Ensure compliance with Novartis internal quality standards, relevant regulatory requirements, and service level agreements.
- Assist in internal and external audits by collecting and presenting requested process data/reports.
Process and Data Management:
- Support in product quality reviews (APQR), including extracting data, interpreting results, and drafting conclusions.
- Maintain schedules and update data in e-compass files, ensuring product robustness.
Regulatory & Supplier Communication:
- Interact with contract manufacturing organizations (CMOs) and manufacturing sites to support APQR and regulatory reviews.
- Maintain and update Marketing Authorization Holder (MAH) and Batch Release Schedule (BRS).
Training & Development:
- Focus on completing assigned training and developing an understanding of data insights through digital tools.
- Comply with internal systems, processes, and time tracking requirements.

Minimum Requirements:

Education:
- M.Pharm, MBA, Engineering, or equivalent degree from a reputed institute.
Experience:
- Minimum 1 year of experience in Quality Assurance, Regulatory, or in manufacturing pharmaceutical drug substances/products/medical devices.
Skills:
- Basic awareness of GxP compliance requirements.

Why Novartis?

At Novartis, we are committed to improving and extending people's lives through innovative science and collaborative efforts. Join a team of passionate professionals working toward groundbreaking solutions that positively impact the world.

Benefits and Rewards:
Explore Novartis’ Life Handbook for more on the benefits offered.

Diversity and Inclusion:
Novartis fosters an inclusive work environment with teams that reflect the diversity of the patients we serve.

Accessibility:
If you require accommodation during the recruitment process, please contact diversityandincl.india@novartis.com.

Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Location: Hyderabad, Telangana, India

Be part of Novartis and contribute to transforming the future of medicine. Apply Now

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Specialist-Quality Operations

Job Description

Specialist - Quality Operations

Role Summary:

Key Responsibilities:

Minimum Requirements:

Why Novartis?

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