Pharmaceutical QA Specialist

**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