Job Description

About the Role

We are seeking a dedicated QA Specialist to join our team at Eramol. This is a pivotal role within the Quality function, responsible for QA operations, service development, facility monitoring & control, and quality management systems.

As QA Specialist, you will act as the Quality lead within a designated Business Unit, ensuring compliance with all relevant legislation and internal standards. You will also play a key role in maintaining and developing our Pharmaceutical Quality System (PQS), supporting audits, and driving a culture of continuous improvement across the business.

This is an excellent opportunity for someone with a strong QA background in sterile environments, who is ready to take on responsibility, lead initiatives, and mentor others in a growing and innovative company.

Key Responsibilities

Service Development

Maintain and develop the company's global PQS in line with current regulatory requirements. Develop and monitor PQS KPIs, presenting findings at monthly management reviews. Drive continuous improvement of the QMS and maintain oversight of site compliance. Support regulatory and third-party audits, ensuring operational readiness at all times. Oversee GMP & GDP refresher training and documentation for all staff. Support the Ireland facility in QMS management, local self-inspections, and change controls. Lead risk management, quality projects, and cross-departmental QA support.

Leadership & Team Development

Act as a role model, deputising for the QA Manager when required. Train and mentor QA Officers, ensuring full compliance with GMP & GDP training requirements. Deliver engaging QA training sessions across the business. Support continuous improvement initiatives across Production and QA.

Facility Monitoring & Control

Review and manage environmental monitoring data, ensuring compliance with site procedures. Support the management of site environmental monitoring systems.

Quality Management Systems (QMS)

Lead PQS activities within a designated Business Unit, including deviations, CAPAs, self-inspections, and documentation management. Maintain the Validation Master Plan and Planned Preventative Maintenance Program. Support supplier quality management, including audits and assessments.

Quality Operations

Provide specialist QA support on the floor for sterile/non-sterile manufacturing and distribution. Oversee the approval of batch records, ensuring compliance with GMP and product specifications. Train production staff on quality standards and ensure adherence to protocols. Monitor production, storage, and distribution processes to maintain sterility and quality.

Education & Development

Deliver GMP/GDP training across QA, operational, and non-operational teams. Maintain up-to-date knowledge of regulatory requirements and continuously develop personal expertise.

Other Responsibilities

Actively contribute to projects and business improvements. Demonstrate Eramol values: Transparency, Innovation, Delivery. Take responsibility for personal development and contribute to team success.

Essential Experience & Skills

Proven experience in QA within a sterile environment. Strong communication skills with a confident, personable style. Excellent attention to detail, with the ability to multitask and prioritise effectively. Strong problem-solving abilities and a solution-focused mindset. Ability to work independently and collaboratively across cross-functional teams. Solid knowledge of GMP and GDP principles. Competent in MS Office (Word, Excel, PowerPoint).

Desirable Experience

Degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline. Previous experience in a similar QA role. Experience within sterile manufacturing. Knowledge and experience of working in accordance with GxP guidelines.

What We Offer

Starting salary of 37,500 (based on a 37.5-hour work week) 25 days of annual leave, plus bank holidays Enhanced family friendly leave policies Access to an Employee Assistance Programme (EAP) Social events Opportunities for career growth and development Additionally parking is available on site (free)
Job Types: Full-time, Permanent

Pay: 37,500.00 per year

Benefits:

Company events Discounted or free food Enhanced maternity leave Enhanced paternity leave Free parking Health & wellbeing programme On-site parking Sick pay
Work Location: In person