Manager-Quality Assurance

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