Associate Analyst, Quality Operations

Job Description Summary

-Supports all GxP activities in the Quality department.
-Administers Quality Systems/ Processes including documentation, metrics and monitoring of actions.
-Supports establishment of Quality operational processes.
-Performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards. Supports Quality Projects and initiatives.

 

Job Description

Major Accountabilities:

• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones, Functional Breadth, Collaborating across boundaries
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key Performance Indicators:

• Customer satisfaction
• Punctuality rate
• Jobs done on time, following the specified cycle time
• Consistent compliance with GMP and Health, Safety and Environment guidelines and Standard Operating Procedures
• No complaints with regulatory inspections

Work Experience:

• Quality Assurance
• Quality Control
• Quality Management Systems
• Technological Expertise
• Environmental Monitoring
• Release Management
• Good Manufacturing Practices (cGMP)
• Quality Compliance
• Technological Expertise
• Audit & Inspection Management
• SOP (Standard Operation Procedure) Management
• Documentation Management

Skills:

• Collaboration
• Dealing With Ambiguity
• Deadline Adherence
• Health & Safety Regulations Knowledge
• Monitoring
• Punctuality
• Regulatory requirements knowledge
• Problem Solving Skills
• Leadership
• Communication skills
• Data Integrity
• Digital saviness

Languages:

• English.

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Deadline Adherence, Dealing With Ambiguity, Digital saviness, Health & Safety Regulations Knowledge, Leadership, monitoring, Problem Solving Skills, Punctuality, Regulatory Requirements knowledge