Job Description
We are seeking an In-Process Quality Assurance Specialist to join our team at a company in Tipperary. This is a permanent role with shift work.
This person will provide quality support to production activities, requiring minimum 2 years' experience working in a Pharmaceutical GMP industry, preferably in an accredited HPRA or FDA environment. A 3rd level education in science, engineering or a related discipline is essential.
Key Responsibilities:
Support batch manufacture by performing in-process checks during batch manufacture and line sign-off prior to start of batch manufacture.
Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs for accuracy, completeness, and compliance to GMP and procedural requirements.
Review Standard Operation Procedures for manufacturing operations and cleaning.
Participate in investigations related to manufacturing.
Prepare Standard Operating Procedures, investigations, reports, and forms as required.
Perform swab sampling (bioburden and chemical).
Conduct internal and process audits.
Monitor GMP compliance during production activities.
Identify and address documentation errors, develop preventive actions to reduce or eliminate recurrences.
Manage retain samples.
Sampling and inspection activities.
Issue documentation for production - Batch Record, SOPs.