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.
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