Quality Assurance Officer

Detailed Job Role

Oversee quality systems, conduct audits, approve batches, implement SOPs and CAPAs to maintain pharma quality standards.

KRA (Key Responsibility Areas)

Audits, batch reviews, SOP updates, CAPA management, GMP compliance

KPI (Key Performance Indicators)

Deviation closure rate, audit pass, CAPA closure time, complaint frequency

Job Summary:

We are seeking a diligent Quality Assurance Officer to oversee quality systems, conduct audits, approve batches, and ensure compliance with GMP standards. The ideal candidate will implement and maintain SOPs, manage CAPAs, and drive continuous improvement in pharmaceutical quality management.

Key Responsibilities:

• Oversee and maintain the pharmaceutical quality management system.
• Conduct internal audits and participate in regulatory inspections.
• Review and approve batches in accordance with GMP guidelines.
• Implement and update Standard Operating Procedures (SOPs).
• Manage Corrective and Preventive Actions (CAPAs) to resolve deviations.
• Investigate quality complaints and ensure timely resolution.
• Ensure compliance with regulatory requirements and company policies.

Key Performance Indicators (KPIs):

• Deviation closure rate
• Audit compliance and pass rate
• CAPA closure timeliness
• Frequency and resolution of quality complaints

Skills & Competencies:

• Strong knowledge of GMP, GLP, and quality assurance principles
• Analytical and problem-solving skills
• Attention to detail and documentation accuracy
• Effective communication and teamwork abilities
• Ability to implement process improvements and corrective actions

Education