Quality Assurance Officer – Pharmaceutical Manufacturing

About the role

We are seeking a Quality Assurance Officer to join Pinewood Healthcare’s pharmaceutical manufacturing team. The role ensures that all products are produced in compliance with cGMP, ISO standards and regulatory requirements, supporting both our Dublin and Tipperary sites.

Key responsibilities

• Originating, approving and issuing production documentation and SOPs in line with cGMP.
• Reviewing and approving stability documentation, testing protocols and stability reports.
• Evaluating validation protocols and reports, including process, cleaning and equipment validation.
• Conducting internal and external audits, investigating deviations, OOS results and customer complaints.
• Managing change control, vendor certification, supplier approval and raw‑material review.
• Maintaining ISO standards, temperature monitoring and CAPA reports.
• Liaising with customers for contract‑manufactured products and supporting elemental impurity and excipient risk assessments.

Required profile

• Degree in Chemistry, Pharmacy or Biological Science.
• Experience in the pharmaceutical industry, preferably in QA or QC.
• Strong organisational, problem‑solving and communication skills.
• Ability to work independently and as part of a regulated, fast‑paced manufacturing environment.

Required skills

• cGMP compliance
• SOP authoring and review
• Stability testing and documentation
• Process, cleaning and equipment validation
• CAPA management
• Temperature monitoring
• ISO standards implementation