Job Purpose :
Manage all quality aspects of actual and potential deviations / non-conformances according to CH QS SOPs related to GxP activities.
To ensure that observations are appropriately documented and CAPAs are established. Identify new Quality risks across all functions, trend analyse type of observations (reported through Gemba) and help functions understand root causes.
Educational Requirement :
Minimum Level of Education : Pharm, Pharm D. or MSc (Chemistry
Area of Specialisation : Pharmacy
Experience Requirement :
Skill Requirement :
Awareness of Legal & Regulatory Framework in Pakistan (DRAP)
Courses in Quality Risk Management
Key Responsibilities :
To ensure Products meet the necessary quality standards through conducting Gembas across all GxP activities, verifying the quality system's continued compliance with all applicable Quality and Regulatory requirements
Participate in Quality Risk management program; identify new risks, provide risk assessment on product / process through cross functional activities
Trend analyse observations, identify root causes and mitigate impact on Product / process Quality in line with GMP requirements
Support the cGMP knowledge management program with HR and Training Department to ensure cGMP proficiency and competency for each working category.
Interface with Manufacturing, QC laboratory, Engineering and other technical disciplines to represent Compliance with an objective to assure compliance at all levels.
Develop PowerBI, implement and establish dashboards, accountability boards and metrics to measure Compliance performance
Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Any other responsibility assigned from time to time as per business requirements.