QA Specialist

Purpose

This position is vital in safeguarding product quality and ensuring compliance with current Good Manufacturing Practice (cGMP) standards on site. The role oversees manufacturing, storage, and packaging operations to confirm adherence to regulatory requirements while promoting ongoing improvements and readiness for audits.

Responsibilities

• Act as the main QA liaison for systems and processes by offering expert advice on quality-related concerns and conducting thorough reviews of documentation, investigations, and reports.
• Perform internal audits and assist with supplier and regulatory inspections, ensuring that all product deviations are addressed and resolved before product release.
• Collaborate with operational teams to facilitate the prompt closure of quality-related actions, minimize recurring issues through trend and data analysis, and improve procedures and practices.
• Assist in developing and delivering training programs related to GMP to maintain high-quality standards throughout the site.

Requirements

• Possess a third-level degree preferably in Science or a related field.
• At least two years of experience in a QA role within a cGMP-regulated environment.
• Comprehensive understanding of cGMP regulations with meticulous attention to detail.
• Strong interpersonal and presentation skills along with proficiency in relevant computer software.

Personal Characteristics

• Accountable, taking ownership of actions and results.
• Self-motivated and capable of working independently with minimal supervision.
• A cooperative team player with excellent communication abilities.
• Flexible and adaptable to change, focused on delivering measurable outcomes in a dynamic setting.