Pharmalliance Consulting Ltd | Full time
Pharmalliance offers expert support to pharmaceutical companies to maintain and increase quality compliance levels.
We specialize in cGMP Compliance, Remediation and Contamination Control and have a suite of services to help you stay compliant no matter what your stage of development.
Job Description
Position Overview
An experienced QA / Inspection Analyst is required to support quality and compliance activities at a regulated life sciences facility in County Wexford. This role supports inspection and release activities, ensuring compliance with GMP, GDP, HPRA regulations, and internal quality systems. The successful candidate will work closely with Quality, Operations, and external suppliers to ensure accurate documentation, traceability, and regulatory compliance across receiving, inspection, and distribution activities.
Key Responsibility
Perform incoming inspection of tissue and cell products in line with regulatory and internal requirements
Review labels, certificates, and associated documentation for accuracy, completeness, and compliance
Coordinate distribution activities in accordance with regulatory and quality requirements
Ensure ongoing compliance with GMP, GDP, HPRA regulations and internal quality procedures
Identify non-conformances, raise deviations or variances, and support quality investigations
Communicate with suppliers to resolve quality or documentation issues as required
Verify traceability documentation and ensure records are complete, accurate, and audit‑ready
Maintain inspection records, ensuring proper filing, archiving, and data integrity
Support internal, customer, and regulatory audits
Support continuous improvement initiatives within the Quality function
Support electronic quality record management using a Zoho‑based inspection workflow system
Requirements
Education
Bachelor’s degree in a relevant scientific or engineering discipline (Life Sciences, Quality, Regulatory, or related field).
Experience
Proven experience in a Quality Analyst, QA, or Inspection role within a regulated environment, preferably within life sciences, pharmaceutical, or medical products.
Technical Knowledge
Strong knowledge of GMP, GDP, HPRA regulations, and applicable regulatory guidelines
Experience reviewing quality documentation and traceability records
Familiarity with electronic quality management systems (eQMS); Zoho experience is an advantage
Skills
Strong attention to detail and organisational skills
Excellent communication skills with the ability to engage internal stakeholders and suppliers
Analytical and problem‑solving mindset with a focus on continuous improvement
Ability to work independently while managing multiple priorities
Must be legally eligible to work in Ireland.
#J-18808-Ljbffr