Quality Assurance Specialist

Role Overview

The Quality Assurance Specialist plays a key role in upholding compliance across various site operations, including manufacturing, quality systems, quality control, validation, facilities, maintenance, engineering, and materials handling, ensuring adherence to required regulatory standards and site protocols.

Key Responsibilities

• Ensure comprehensive quality compliance at the Raheen site across manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Maintain adherence to the current Good Manufacturing Practices (cGMP).
• Work collaboratively with cross-functional teams to address issues, finalize investigations, and sustain compliance.
• Review and approve critical documents such as failure investigations, CAPA, SOPs, GxP documentation, and change control forms.
• Lead or assist root cause analysis, ensuring the execution of suitable CAPA to avoid future occurrences as a quality approver.
• Evaluate procedures, policies, and quality system documents to guarantee alignment with company policies as well as local and international regulatory demands.
• Monitor and analyze metrics related to site quality systems.
• Contribute to continuous improvement initiatives through idea generation, initiation, and implementation.
• Participate in internal, regulatory, and customer audits as required.
• Provide training on quality system processes to personnel when necessary.
• Perform other duties as assigned.

Qualifications and Experience

• Associate Specialist: Bachelor's degree in a scientific or related discipline or equivalent experience.
• Specialist: Bachelor's degree plus a minimum of two years relevant experience in pharmaceutical or allied industries or equivalent.
• Senior Specialist: Bachelor's degree with at least five years relevant experience or Master's degree with four years experience in pharmaceutical or related sectors or equivalent.