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)