Job Responsibilities
Act as QA In-charge for the plant.
Drive Quality KPIs.
Lead QA documentation, CAPA, deviations, change control, risk assessments and validation review.
Coordinate customer, internal and regulatory audits.
Ensure compliance with GMP, cGMP, ISO 9001 principles and applicable regulatory requirements.
Review SOPs, BMR/BPR, specifications and quality records.
Support qualification/validation activities.
Train employees on GMP, GDP and quality systems.
Lead continuous improvement and inspection readiness.
Core Functional Competencies
Robust knowledge of QA systems, documentation, GMP/cGMP, GDP and ISO standards.
Expertise in CAPA, deviation, OOS/OOT investigation, change control and risk management.
Internal/external audit planning, execution and compliance monitoring.
Regulatory inspection handling and root cause analysis.
Behavioral Competencies
Leadership and team management.
Cross-functional collaboration.
Solid communication and decision-making.
Analytical thinking, problem solving and proactive quality culture.