Specialist-Quality Operations

1+ years

Not Disclosed

Hyderabad

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.

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Specialist-Quality Operations

Job Description

Main Purpose of Role:

Key Responsibilities:

Quality Operations Services:

Annual Product Quality Review (APQR):

Marketing Authorization Holder (MAH) Review:

Key Performance Indicators:

Qualifications:

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