Ensuring GMP and regulatory compliance in API manufacturing.
Handling audits and inspections from national and international regulatory authorities (USFDA, EU GMP, MHRA, etc.).
Overseeing quality control systems, documentation, and training.
Investigating deviations, initiating corrective actions (CAPA), and ensuring compliance.
Leading internal and external quality audits.
Review and approval of batch manufacturing records and analytical documentation.
Developing, implementing, and managing standard operating procedures (SOPs).
Managing validation protocols, stability studies, and calibration schedules.
Coordinating with cross-functional teams to maintain quality standards.
Training and mentoring QA and QC teams to enhance their capabilities and adherence to standards.
Ensuring effective implementation and management of the Quality Management System (QMS).
Regularly reviewing and improving QMS documentation and procedures to enhance efficiency.
Monitoring and reporting key quality indicators and performance metrics to senior management.
Ensuring continuous improvement of quality practices through regular gap analyses and risk assessments.

Preferred candidate profile

Demonstrated experience in Quality Assurance in the pharmaceutical/API industry.
Proven capability in managing regulatory audits and inspections, especially from foreign authorities like USFDA, WHO-GMP, EDQM, ANVISA etc.
Proactive professional with strong analytical skills and attention to detail.
Excellent communication, leadership, and organizational abilities.
Ability to work collaboratively in a cross-functional team environment.

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