QA Associate

Role overview

As a QA Associate, you will report to the Site Director of Quality and help ensure that products made, tested, released, and distributed through contract manufacturing organisations and contract laboratories meet cGMP, GDP, marketing authorisations, and Bimeda quality standards. The role has broad oversight across external partners, quality systems, product lifecycle activities, complaints, recalls, training, and inspection readiness.

External partner quality oversight

• Set up and run regular meetings and quality reviews with CMOs, contract labs, and logistics partners, covering performance trends, complaints, deviations, CAPAs, change controls, and open commitments.
• Assess and approve validation protocols, validation reports, and sampling plans, making sure the statistical basis is appropriate.
• Take part in CMO audits and contract laboratory qualification, and monitor that corrective actions and follow-up items are completed on time.
• Keep supply chain maps current for CMOs and confirm GDP compliance across the logistics network, including support for 3PL and contract lab oversight.
• Coordinate and approve QC method transfers to CMOs, ensuring data integrity, comparability, acceptance criteria, and transfer documentation are in place.

Quality management system ownership

• Maintain and revise the Quality Manual/SMF so that it stays aligned with licences and internal BAHL procedures.
• Administer and approve change controls, deviations/LIR, CAPAs, document approvals, document reconciliation, and archiving for CMO batches and related records.
• Plan and carry out internal audits, then feed the findings into management review, KPI tracking, and improvement initiatives.
• Oversee the QA aspect of the calibration programme and support lifecycle controls for QC equipment transfers.
• Issue, reconcile, and archive logbooks in line with data integrity expectations.

Product lifecycle and technical quality activities

• Review and approve CMO validation protocols and validation reports, maintaining clear traceability from protocol through to report.
• Set up and monitor the stability programme, including protocols, sample pulls, investigations, reporting, and commitments.
• Support environmental monitoring data review and trending where retained BAHL facilities or lab partners are involved.
• Coordinate finished product and raw material testing through contract laboratories and CMOs in line with specifications and release needs.
• Manage BAHL artwork processes and CMO artwork approvals, keeping them tied into change control.

Complaints, deviations, and investigations

• Lead investigations for customer and supplier complaints, using root cause analysis, risk assessment, and CAPA effectiveness checks.
• Oversee deviations raised by CMOs and internally, ensuring they are closed in a timely manner and that product impact is assessed.
• Handle raw material and finished product rejections, including appropriate disposition and escalation.
• Prepare and present BAHL CMO summary PQRs, CMO PQRs, and BAHL PQRs, ensuring annual product quality reviews are completed and actions are tracked.

Regulatory support and recall readiness

• Work with the BAHL Responsible Person for GDP and Regulatory Affairs on HPRA and other authority notifications, including quality defects, recalls, major changes, licence variations, and CMO/3PL changes.
• Maintain recall preparedness through mock recalls, distribution traceability, and retained sample checks, and coordinate partner activity when a live recall is needed.
• Contribute quality inputs for licence variation work, including validation impact, stability commitments, artwork updates, and SMF updates.
• Support decisions on HPRA notification and variation routes and timing, and help close out matters such as site testing or distribution cessation in line with regulatory guidance and BAHL procedures.

Samples, records, and archiving

• Own the reference and retain sample programme, including storage conditions, chain of custody, retention periods, retrieval, and alignment with MA/HPRA expectations and SOPs.
• Oversee archiving for CMO and contract laboratory documentation so that complete product histories are always available and inspection-ready.

Training, SOPs, and communication

• Maintain and write SOPs, CMO questionnaires, and other controlled documents, while ensuring version control and training assignment are managed correctly.
• Deliver QA training on topics such as data integrity, documentation, investigations, and change control, and monitor training effectiveness.
• Contribute to management review with updates on QMS performance and training compliance.
• Lead regular CMO meetings and wider cross-functional forums, documenting minutes, decisions, and action items.
• Prepare quality inputs and action tracking for health authority audits and customer inspections, including responses and CAPA follow-up.

About the company

Bimeda is a global developer, manufacturer, and marketer of veterinary medicines and animal health products. With more than 50 years of experience, the company focuses on science-led solutions that support animal health, wellbeing, and productivity. Its international network includes six R&D centres across four continents and nine manufacturing sites across seven countries, supporting a broad portfolio that includes sterile injectables, vaccines, nutritional boluses, feed additives, tablets, water-soluble powders, pastes, and non-sterile liquids. Bimeda also works as a contract manufacturing and R&D partner for organisations in the animal health sector.

Working arrangement

This position is based on site five days per week at 21 Spruce Avenue, Stillorgan Industrial Estate, Sandyford, A94 K5C8, Ireland. The working week is 39 hours.

Compensation

The annual salary for this role is €36,606.

Additional information

The employer is Bimeda Animal Health Ltd. This job description is not exhaustive; the successful candidate may be asked to perform other relevant duties at a level appropriate to the post, and the duties may evolve over time as business priorities change. By applying, you confirm that you have read and accept the privacy policy.

Essential requirements

You should have a BSc in a science discipline or a closely related field, along with 2 to 3 years of relevant experience in a regulated pharmaceutical QA/QC environment. You also need a solid understanding of pharmaceutical QA methods, cGMP, quality systems, and analytical chemistry.

Desirable experience

It would be an advantage to have worked with external manufacturing oversight or contract laboratory management, and to be familiar with HPRA, EU GMP/GDP, and lifecycle documentation such as SMFs and PQRs. Knowledge of sampling standards such as ANSI/ASQ, stability studies, IQ/OQ/PQ, and data integrity principles such as ALCOA+ would also be useful.

Personal attributes

The right candidate will bring high integrity, strong attention to detail, analytical thinking, good organisation, teamwork, and a proactive self-starting approach. Clear communication skills are important for managing partner relationships and driving timely closure of quality actions.