Quality Assurance Executive III – Sterile Injectables Remote (Ireland) – 12-month Fixed Term Contract (Maternity Cover) **Candidates must be currently based in Ireland and possess valid, unrestricted authorization to work in Ireland at the time of Application.
Visa Sponsorship is not available for this role.
About the company Our client is a global healthcare organisation committed to empowering people worldwide to live healthier at every stage of life.
They provide access to high-quality medicines across a wide range of therapeutic areas and are recognised for their focus on sustainable operations, innovation, and strong partnerships.
This is an excellent opportunity to join a collaborative, purpose-driven organisation on a 12-month contract where you can make a real impact on patient health.
The opportunity As Quality Assurance Executive III, you will play a key role in ensuring the quality and compliance of sterile injectable, ophthalmic and medical device products supplied to the US market from third party manufacturers (TPMs) and vendors.
You will work within a global quality framework, supporting batch release, complaint and deviation management, and oversight of external manufacturing partners.
This is a remote role within Ireland, with occasional travel to site or partner locations as required.
It is ideally suited to a QA or QC professional with 4–6 years' pharmaceutical experience, strong knowledge of sterile manufacture, and an interest in supplier/TPM quality and distribution.
Key responsibilities Review batch documentation from TPMs for approval of shipment and distribution of sterile injectable, ophthalmic and medical device products to the US market Review deviations, out-of-specification (OOS) results and incident reports associated with these products Lead or support investigation and review of product complaints, stability OOS and non-conformances from TPMs and vendors Support preparation of critical quality notifications to global functions and Health Authorities where required Ensure CAPAs are implemented and closed in a timely and effective manner Perform new vendor/TPM assessments, approval and ongoing maintenance, including generation and review of Quality/Technical Agreements Prepare and review change controls from vendors/TPMs for approval, including associated documentation such as artwork changes Prepare and review Product Quality Review (PQR) reports for products manufactured at TPMs Review equipment, process, analytical method validation protocols and reports, as well as stability study protocols and reports Act as QA reviewer on TPM research and development projects as needed Where applicable, act as Deputy Responsible Person (RP) in line with internal procedures, supporting compliance with EU Good Distribution Practice (GDP) for medicinal products within the EU About you: Bachelor's degree (or equivalent) in a life science or pharmacy Approximately 4–6 years' experience in Quality Assurance and/or Quality Control within a pharmaceutical company Experience in a sterile manufacturing environment (e.g. sterile injectables, ophthalmic products or similar aseptic operations) Strong knowledge of pharmaceutical quality systems and sterile manufacture requirements Good understanding of cGMP and relevant regulations/guidelines (e.g. ISO, US FDA, EU GMP, MHRA, WHO) Proven experience reviewing complex technical and quality documentation (batch records, deviations, validations, stability, change controls) Strong problem-solving skills with the ability to analyse complex issues and use sound judgement to drive decisions Excellent written and verbal communication skills, with the ability to work effectively with cross-functional and global teams Proficiency in standard IT tools (e.g. Microsoft Office; experience with quality systems/ERPs/LIMS is an advantage) Ability to work effectively in a remote environment, managing workload and stakeholders virtually Desirable: Experience in supplier quality management and/or third-party manufacturing oversight Experience interacting with Health Authorities or supporting regulatory inspections/audits Previous exposure to GDP and/or experience supporting a Responsible Person function What's on offer: 12-month fixed term contract (maternity cover) with competitive salary Remote role within Ireland, with flexibility and work–life balance Exposure to global quality operations and third-party manufacturing Inclusive, collaborative culture with a strong focus on purpose and making a difference to patients' lives