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Job Description
We're looking for a proactive and detail-oriented Q.A Compliance Lead Manager to join our dynamic quality team. In this critical role, you'll oversee and ensure the effectiveness of our Quality Management Systems, playing a key part in driving compliance and upholding the highest product standards
Key Responsibilities:
- Leading the Deviation Management System, ensuring thorough investigations and timely, effective implementation of Corrective and Preventive Actions (CAPAs).
- Managing the customer complaint process, including root cause analysis and follow-up CAPAs to boost satisfaction and meet regulatory expectations.
- Championing risk management activities across all operational areas, developing and monitoring mitigation strategies.
- • Overseeing the CAPA system site-wide, ensuring traceability, compliance, and effectiveness of corrective actions.
Job Requirements
- Bachelor's degree in Science or pharmacy (preferred).
- +8 years in a quality role, ideally within sterile manufacturing environments.
- Solid knowledge of GMP regulations and local regulatory standards.
- Familiarity with validation protocols (IQ, OQ, PQ) and qualification processes for equipment, utilities, and facilities.
- Strong track record in compliance activities, audit preparation, and quality documentation.
- Exceptional analytical thinking, problem-solving, and cross-functional communication skills.
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