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Senior Qa Operations Specialist, Rlt Cn

5-8 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: BE/BCS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s a concise and structured summary of the job description:


QA Specialist – Quality Assurance Operations
Location: Haiyan, Zhejiang Province, China

About Novartis:
At Novartis, we believe in advancing innovative science through collaboration and support to improve patients' lives. Join a passionate community committed to breakthroughs that transform healthcare.

About the Role:
As a QA Specialist, you will ensure compliance with cGxP standards for products under your responsibility across development, transfer, and commercialization stages. You will provide leadership, oversee QA operations, and support product release to meet business needs.

Key Responsibilities:

  • Develop and manage local SOPs and ensure proper documentation and archiving.
  • Oversee training management and compliance tracking for QA teams.
  • Support validation activities, CAPA management, and batch record review.
  • Collaborate on GxP audits and inspections, ensuring readiness and compliance.
  • Drive QA operational excellence and promote safety and quality cultures.
  • Guarantee the effectiveness of the Business Continuity Plan and participate in project crisis management as needed.
  • Monitor HSE (Health, Safety, and Environment) incidents and follow up on action items.
  • Lead inspection readiness activities and represent QA during audits and regulatory inspections.

Essential Requirements:

  • 5–8 years of QA experience in a pharmaceutical manufacturing environment, particularly with sterility products.
  • Strong understanding of cGMP standards and experience in audit/inspection management.
  • University degree in Pharmacy, Engineering, Chemistry, Biotechnology, or equivalent.
  • Proficiency in English (written and spoken); knowledge of the local language is a plus.
  • Expertise in GMP quality assurance, manufacturing processes, and risk management.
  • Advanced communication and collaboration skills; result-oriented with a strong focus on quality and compliance.

Why Novartis:
Helping people with diseases takes more than innovative science—it requires a community of smart, passionate individuals working together to inspire breakthroughs.

Accessibility and Accommodation:
Novartis provides reasonable accommodations for individuals with disabilities. For support, email diversityandincl.china@novartis.com with the job requisition number.

Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full-Time, Regular

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