Job description

Job Title: Quality Specialist
Role Type: Full Time, Permanent
Location: Dublin 12

Force Recruitment are excited to be partnered with a growing Irish Pharmaceutical distribution company, to recruit a Quality Specialist on a Full Time, Permanent basis to work in their new distribution site in Dublin 12. The role is responsible for the quality oversight of the distribution of products in the supply chain of the business. Working closely with Logistics, Customer Service and Commercial functions, and reporting to the Quality Manager, this is a fully on-site role.

Duties & Responsibilities:

Assist in the development, implementation, and maintenance of the Quality Management System.
Ensure compliance with Good Distribution Practice (GDP) and Health Products Regulatory Authority (HPRA) guidelines.
Ensure quality processes are understood and implemented through continuous staff training.
Oversee procurement and supply of authorised products from approved suppliers and customers.
Assist in approving outsourced services, route qualifications, and maintain Quality Technical Agreements.
Review, draft, and approve documentation (SOPs, deviations, change controls, etc.).
Perform Bona Fide checks on suppliers and customers, and maintain a risk management culture.
Manage product returns, temperature-controlled shipments, and escalate issues like Adverse Reactions (ADRs) or product defects.
Coordinate product recalls and act as deputy Responsible Person (dRP) in the absence of the RP.
Ensure continuity of supply without compromising product quality, safety, or compliance.
Escalate falsified medicines and ensure quality records are accurate within the Quality Management System.

Qualifications & Experience Required:

3+ years QA experience in a Pharmaceutical or HPRA/FDA/EU & GMP/GDP regulated environment
RP Qualification is preferred but support will be provided to gain this qualification if necessary.
Thorough knowledge of temperature-controlled activities
Thorough knowledge of cGMPs/GDPs and global regulatory requirements
Sound awareness and understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
Good verbal and written communication skills with well-structured communication and ability to present to various audience levels

Benefits

Health insurance Allowance
Pension
Life Assurance
23 Days Annual Leave (including good Friday)
4 Wellness days per year (1 per quarter)