Pharmacovigilance Quality CAPA Specialist Job at Sandoz
Company: Sandoz
Division: SANDOZ
Business Unit: Administration & Facility
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Work Mode: Hybrid
Location: Telangana, India
Shift: Day Shift (No Shift Work)
Job Overview
Sandoz is hiring a Pharmacovigilance Quality professional to support Patient Safety (PS), QPPV Office, deviation management, CAPA processes, audits, and global regulatory compliance.
This role plays a critical part in maintaining pharmacovigilance quality systems, inspection readiness, and continuous compliance with worldwide safety regulations. Pharmacovigilance Quality CAPA Specialist Job at Sandoz
Key Responsibilities
- Support development, management, and implementation of deviations, CAPAs, and effectiveness checks across the Patient Safety organization
- Act as CAPA Coordinator in the GxQEM system, including tracking and management
- Support inspection and audit activities, including audit responses and CAPA oversight
- Assist in PV performance oversight, including creation and monitoring of metrics, KPIs, and KQIs for Patient Safety and vendors
- Support the QPPV in meeting legislative and regulatory requirements
- Participate in deviation management discussions and quality-related activities
- Review emerging global pharmacovigilance regulations, perform impact assessments, and support required process updates
- Manage allocated deviations and quality events throughout the deviation lifecycle
- Support QPPV Office projects, quality management system activities, and SOP development
- Identify potential risks through metrics analysis and escalate compliance issues in a timely manner
- Coordinate documentation, archiving, and administrative activities within the QPPV Office
Required Experience & Skills
Essential Requirements
- Minimum 2 years of experience in drug development, clinical safety, pharmacovigilance, or related areas
- Strong knowledge of PV quality systems, deviations, CAPA, audits, and inspections
- Good negotiation, conflict resolution, and problem-solving abilities
- Strong written and verbal communication and presentation skills
- Results-driven, proactive, and accountable working style
- Ability to work effectively under pressure
- Strong planning, coordination, and computer skills
Why Join Sandoz?
Generic and biosimilar medicines form the backbone of global healthcare. In 2024, Sandoz delivered more than 900 million patient treatments across 100+ countries. Pharmacovigilance Quality CAPA Specialist Job at Sandoz
Sandoz continues to invest in new development capabilities, manufacturing sites, acquisitions, and partnerships—creating opportunities to shape the future of affordable, high-quality medicines worldwide.
Employees benefit from an open, collaborative culture, flexible hybrid careers, strong focus on diversity and inclusion, and continuous personal and professional growth. Pharmacovigilance Quality CAPA Specialist Job at Sandoz
Diversity & Inclusion
Sandoz is committed to equal employment opportunities and a diverse, inclusive workplace. All qualified applicants are considered without discrimination. Pharmacovigilance Quality CAPA Specialist Job at Sandoz
How to Apply
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