Quality Specialist

JO-26

Quality Specialist

Position Type: Full-time

Location: Remote (within the Sligo region, Ireland)

Our client is a clinical-stage speciality pharmaceutical company dedicated to the development and commercialisation of therapies for patients living with rare and orphan diseases. They are seeking a Quality Specialist, reporting to the VP of Quality, you will play a key role in providing quality oversight of outsourced drug substance manufacturing activities in Sligo.

This is an excellent opportunity for a quality professional with experience in pharmaceutical manufacturing who is looking to broaden their exposure within a collaborative and growing organisation.

On Offer

Competitive salary of €45,000-€55,000, depending on experience.

Remote working within the Sligo region. Will be required to visit drug substance manufacturing facility in Sligo on a weekly basis.

Opportunity to work within an innovative pharmaceutical company developing therapies for patients with significant unmet medical needs.

Exposure to global contract manufacturing operations and cross-functional collaboration.

Supportive and collaborative working environment with opportunities for professional development.

Responsibilities

• Act as the sponsor's Person in Plant (PiP) at designated drug substance manufacturing sites.
• Review manufacturing batch documentation to ensure compliance with approved product dossiers and regulatory requirements.
• Provide quality oversight of third-party manufacturing partners through routine engagement, performance monitoring and quality metrics.
• Participate in quality risk assessments supporting product changes, deviations and quality events.
• Assist in the development, review and maintenance of Standard Operating Procedures (SOPs).
• Support investigations relating to temperature excursions and participate in shipping lane risk assessments and validation activities.
• Provide general quality and compliance support as directed by the Vice President of Quality.
• Foster strong working relationships with internal stakeholders and external manufacturing partners to ensure the highest standards of product quality and compliance.

Requirements

• Bachelor's degree in Chemistry (preferred) or another relevant scientific discipline.
• Min 3 years' experience within the pharmaceutical industry.
• Experience supporting small molecule pharmaceutical products preferred.
• Experience working with contract manufacturing organisations (CMOs) is advantageous.
• Strong understanding of EU GMP regulations and pharmaceutical quality requirements.
• Demonstrated ability to interpret regulatory expectations and implement sustainable quality practices.
• Understanding of pharmaceutical batch documentation review.
• Experience with small molecule synthetic manufacturing processes is desirable.
• Familiarity with quality risk management principles and pharmaceutical investigations is an advantage.
• Excellent written and verbal communication skills.
• Strong organisational skills with the ability to manage multiple priorities independently.
• Self-motivated with a proactive approach to problem-solving.
• High attention to detail and commitment to quality.
• Proficient in Microsoft Office applications.