Quality Assurance Compliance Specialist

Jacksonstone Recruitment Ltd; Wicklow; On-site; EUR 50,000 - 70,000; Full time

Job summary

Jacksonstone Recruitment Ltd is seeking a motivated QA Compliance Specialist to join a pharmaceutical quality team on a specified purpose contract. The role focuses on PQS maintenance, GMP compliance, supplier quality and CAPA management.

You will report to the QA Compliance Manager and collaborate across disciplines to ensure regulatory readiness, drive continuous improvement and uphold the highest standards of pharmaceutical quality.

Qualifications

• Minimum two years in pharma or five+ years in pharmaceutical quality.
• Excellent written communications and documentation skills.
• Strong IT skills and attention to detail.
• Ability to work across multiple departments and manage priorities.

Responsibilities

• Maintain and improve the Pharmaceutical Quality System (PQS) to ensure GMP compliance.
• Support supplier الجودة/inspection activities and CAPA management.
• Coordinate audits, inspections and recall activities as required.
• Draft and review quality documentation (SOPs, policies, work instructions).
• Deliver GMP training and promote a quality culture across the site.

Skills

Two years pharma OR five+ years in QA

Strong communication

IT skills

Attention to detail

Cross-functional collaboration

Education

Bachelors or higher in scientific field

Tools

Quality Management System

CAPA systems

Job description

We are seeking a motivated and detail-oriented QA Compliance Specialist to join a pharmaceutical quality team on a specified purpose contract.

Reporting to the QA Compliance Manager, you will play a key role in maintaining and continuously improving the Pharmaceutical Quality System (PQS), ensuring compliance with current Good Manufacturing Practice (GMP), regulatory requirements and corporate quality standards.

The role will focus on supplier and outsourced activity management, audit and inspection support, CAPA management, product quality compliance, recall coordination and GMP training delivery. You will work collaboratively with cross-functional teams to promote a strong quality culture and maintain the highest standards of pharmaceutical compliance.

Key Responsibilities

Quality Assurance & Compliance

• Support the effective implementation and continuous improvement of the Pharmaceutical Quality System (PQS), ensuring compliance with current regulatory and corporate quality requirements.
• Provide complaint data for Product Quality Reviews (PQRs) and Continued Process Verification (CPV) activities.
• Participate in the preparation for, and follow-up of, regulatory and external inspections.
• Draft, review and approve quality documentation, including SOPs, work instructions, quality policies and other compliance-related documents.
• Coordinate the preparation and submission of Quality Defect Reports, as required.
• Support product recalls and planned mock recalls.
• Lead and participate in Quality Risk Management exercises and continuous improvement initiatives.

Audits, Inspections & CAPA Management

• Coordinate internal and external audit programmes, including the site self-inspection programme.
• Participate in internal audits, self-inspections and quality visits and communication activities.
• Support regulatory inspections and customer audits, ensuring audit findings and complaint-related CAPAs are implemented effectively and within agreed timelines.
• Contribute to site and corporate quality improvement projects as required.

GMP Training

• Assist in the preparation and delivery of routine and annual GMP training.
• Promote a strong GMP culture across the site, working collaboratively with all departments to maintain high standards of quality and compliance.

Supplier Quality Management

• Coordinate the approval of new suppliers of active pharmaceutical ingredients, excipients and packaging materials.
• Ensure appropriate Quality Agreements are established with material manufacturers and suppliers.
• Maintain the Approved Supplier List and coordinate the control and evaluation of planned changes to approved suppliers' manufacturing processes and materials through the change control system.
• Prepare periodic raw material and packaging material reviews in accordance with applicable legislation and requirements.
• Liaise with relevant departments to coordinate review schedules and ensure the timely availability of required information.
• Obtain supplier certifications and supporting documentation, including BSE/TSE, allergen and ISO certifications, as required.
• Participate in the preparation and review of protocols and reports relating to Ship-to-Stock materials and other reduced sampling or testing programmes.
• Conduct formal risk assessments to determine appropriate GMP requirements for excipients in line with relevant guidelines.
• Support global supply projects as required.

Essential Criteria

• A minimum of two years' experience in the pharmaceutical industry, together with a third-level qualification in a scientific discipline; alternatively, five or more years' experience in a pharmaceutical quality function.
• Strong communication, interpersonal and organisational skills.
• Excellent written communication and documentation skills.
• Strong IT skills.
• Excellent attention to detail and sound decision-making abilities.
• The ability to work collaboratively across multiple departments while managing competing priorities.

Why Apply?

This is an excellent opportunity for a quality professional to contribute to a robust pharmaceutical quality system, gain exposure to supplier quality management, audits and regulatory compliance, and support continuous improvement within a GMP-regulated environment.

If you have pharmaceutical QA experience and a strong commitment to quality, compliance and continuous improvement, we would welcome your application.