Quality Assurance Specialist

Job Title: Quality Assurance Specialist
Location: Dublin Ireland
Job Type: Full-time Permanent

About the Company:
We are currently working with a leading company in the pharmaceutical industry specializing in the production of high-quality chemical and pharmaceutical products. Based in Dublin the company is committed to delivering safe and effective solutions in compliance with industry standards and regulatory requirements. The company fosters a collaborative and innovative environment that promotes continuous improvement and development.

Role Overview:
The Quality Assurance Specialist will play a critical role in maintaining and enhancing the quality assurance system within the company. You will work closely with other departments to ensure that products meet the highest standards of quality safety and compliance. The ideal candidate will have a strong background in quality management regulatory standards and an ability to drive improvements in processes and systems.

Key Responsibilities:

• Oversee and manage the day-to-day activities of the quality assurance system ensuring compliance with regulatory requirements (e.g. GMP ISO standards and local regulations).
• Perform internal audits to ensure adherence to company policies procedures and quality standards.
• Review and approve batch records manufacturing instructions and other technical documentation to ensure accuracy and compliance.
• Lead investigations and provide corrective and preventive actions (CAPA) for quality deviations complaints and non-conformances.
• Conduct quality risk assessments and ensure appropriate documentation and records are maintained in line with best practices.
• Collaborate with production and other departments to ensure all products meet specified quality standards.
• Assist with the training and development of quality assurance team members and other staff on quality management systems and compliance.
• Manage the process for supplier qualification and ensure all incoming materials meet quality standards.
• Provide support during external audits inspections and regulatory reviews.
• Drive continuous improvement initiatives within the quality management system to improve product quality and operational efficiency.
• Maintain up-to-date knowledge of industry trends regulations and best practices in quality assurance.

Key Requirements:

• Bachelors degree in Chemistry Pharmaceutical Sciences Life Sciences or a related field.
• A minimum of 2-3 years of experience in a quality assurance role within the pharmaceutical or chemical manufacturing industry.
• Strong understanding of regulatory guidelines such as GMP ISO and ICH.
• Proven experience conducting internal audits and managing CAPA processes.
• Excellent communication skills with the ability to liaise effectively with cross-functional teams and regulatory bodies.
• Detail-oriented with a strong analytical mindset and the ability to solve problems quickly and effectively.
• Proficiency in Microsoft Office Suite and experience with quality management software.
• Strong organizational skills and the ability to manage multiple tasks in a fast-paced environment.

Desirable:

• Experience with supplier qualification and managing external audits.
• Certification in quality management or related fields (e.g. ISO Six Sigma or equivalent).