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Analyst - Quality Services

0-2 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: 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

### **Analyst – Quality Services | Bangalore, India**  
**Job ID:** 283072 | **Location:** Bangalore, Karnataka | **Job Type:** Full-time  

#### **Work Your Magic with Us!**  
Join a global leader in **Healthcare, Life Science, and Electronics**, where your expertise in **quality and regulatory services** will contribute to **change notifications and customer support**. As an **Analyst – Quality Services**, you will play a key role in **managing Field Corrective Actions (FCA) and Change Notifications (CN)**, ensuring regulatory compliance and customer communication excellence.  

### **Your Role**  
- **Field Corrective Actions (FCA) Management**  
  - Monitor and address **time-sensitive FCA requests** according to global standards.  
  - Prepare **FCA letters and supporting documentation** in the CCNS workflow database.  
  - Coordinate **distribution and documentation of FCA communications**.  
  - Escalate **technical issues and report deviations** to the manager.  
- **Change Notification (CN) Handling**  
  - Assess **CN records** to determine customer notification needs.  
  - Prepare and manage **CN letters and distribution schedules**.  
  - Address **customer-related inquiries** on regulatory changes.  
- **Process & Quality Management**  
  - Ensure **timely handling** of inquiries with adherence to SOPs.  
  - Conduct **internal quality checks and maintain performance tracking**.  
  - Utilize **M-Clarity, SFDC, CCNS, and other regulatory tools** effectively.  
  - Identify **errors and inconsistencies** to ensure **high-quality outputs**.  
  - Share knowledge within the team and contribute to strategic projects.  

### **Who You Are**  
- **Education & Experience:**  
  - Science degree in **Biology, Chemistry, Engineering, or related disciplines**.  
  - **Quality-related work experience** (e.g., QA/QC or regulatory roles).  
- **Skills:**  
  - **Strong attention to detail** and ability to handle **time-sensitive tasks**.  
  - Proficiency in **MS Office, SFDC, and database tools**.  
  - **Excellent English communication skills** (written & verbal).  
  - Analytical thinking and **problem-solving mindset**.  
  - Ability to work **independently and in a global team**.  

### **Preferred Qualifications**  
- Experience in **customer support or regulatory documentation**.  
- Advanced knowledge of **MS Excel and database software**.  
- Familiarity with **continuous improvement methodologies**.  

### **What We Offer**  
A dynamic, **inclusive, and innovative** workplace where **curiosity drives progress**.  

🚀 **Apply now and be part of a global team revolutionizing Quality Services!**