Quality Assurance Manager

Position Overview:

We are seeking an experienced and dynamic Quality Assurance (QA) Manager to lead our QA operations at AMRIYA manufacturing facility. The ideal candidate will have a robust background in sterile pharmaceutical manufacturing and a deep understanding of GMP regulations.

Key Responsibilities

• Lead and manage the Quality Assurance department , ensuring full compliance with GMP standards and regulatory requirements.
• Design, implement, and sustain quality systems and procedures for both sterile and non-sterile manufacturing operations.
• Oversee site QA activities with a focus on audit readiness and continued cGMP compliance .
• Direct the investigation of deviations , CAPAs , and OOS incidents related to GxP activities.
• Monitor and verify the compliance of utilities, water systems, and environmental conditions in accordance with quality standards.
• Conduct risk assessments , identifying potential issues through root cause analysis and implementing preventive actions .
• Manage validation and compliance efforts to ensure consistent product quality and adherence to specifications.
• Serve as the point of contact for regulatory communications and coordinate responses with internal stakeholders.
• Collaborate cross-functionally to drive process improvements and maintain high-quality standards.
• Coach, train, and mentor QA personnel, fostering a culture of continuous improvement and quality excellence .

Qualifications

• Bachelor’s or Master’s degree in Pharmacy or Science .
• At least 10 years of experience in Quality Assurance , with a strong background in sterile pharmaceutical manufacturing .
• Minimum 3 years of experience in a leadership or managerial role within QA.
• Familiarity with global regulatory agencies and compliance requirements.
• Demonstrated leadership capabilities , with a track record of managing high-performing QA teams.
• Excellent communication , analytical , and problem-solving skills.
• Detail-oriented and highly organized , with the ability to manage multiple priorities efficiently.