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