Key Technical Skills:
• Regulatory Knowledge regarding cGMP, FDA regulations, ICH guidelines, and other applicable standard like EU GMPs
• Quality Management Systems (QMS)
• Equipment calibration, maintenance, technical know-how of utilities
• Supplier management
• Auditing and Compliance
• Root Cause Analysis (RCA): Understanding and applications of tools such as A3 PPS, 6 M/Cause and effect analysis/ fishbone diagrams, 5 Whys, fault tree analysis, or other RCA methodologies
• Quality Risk Management: Applications of QRM, and its implementation including tools such as FMEA (Failure Mode and Effects Analysis) and risk matrices
• Hands on experience of Electonic systems
• Data Integrity: Ability to detect and handle data integrity issues as per the regulatory expectations
Key Behavioral Skills:
Effective communication.
Collaboration and Teamwork
Problem-Solving
Leadership
Resilience
Critical thinking
Qualification/ Exposure/ Industry Experience
Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.
12-15 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.
Preferred Skills:
Laboratory compliance
SCADA/DCS operations
Lab information management system
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