
Director of Quality Operations
2 days ago
The Head of Quality Assurance is responsible for ensuring the organization maintains a state of readiness for inspections by regulatory agencies.
Key responsibilities include maintaining and improving document control systems, conducting internal audits, and reviewing batch records. The individual will also oversee IPQA activities, review and report on results, and ensure adherence to validation schedules and control sample management.
This role requires excellent leadership skills, effective communication, and strong problem-solving abilities.
Key Responsibilities Include:
- Developing, implementing, maintaining, and improving quality audit processes and GMP compliant systems
- Coordinating vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories, and outsourced services
- Managing Qualified Person audits, Regulatory Inspections, and CAPA close-outs
- Establishing a robust Quality Management System (QMS) for change management, deviation management, incident handling, complaint management, and CAPA
- Leading training programs for GMP compliance and ensuring data integrity
- Overseeing investigations of non-conformances, product recalls, and technology transfers
- Maintaining departmental operational performance, SOPs, and regulatory compliance
Requirements:
- Excellent leadership skills and ability to manage teams effectively
- Effective communication and interpersonal skills
- Strong problem-solving and analytical skills
- Ability to work in a fast-paced environment and adapt to changing priorities
Benefits:
- Opportunity to work with a dynamic team and contribute to the organization's growth and success
- Chance to develop leadership skills and take on new challenges
- Competitive compensation package
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