Job Title: In-Process Quality Assurance Specialist
This is a permanent role with shift work for an experienced professional to join our client's growing team in Tipperary.
We are seeking someone with minimum 2 years' experience working in a Pharmaceutical GMP industry, preferably from an accredited HPRA or FDA environment.
A 3rd level education in science, engineering or a related discipline is essential.
Responsibilities:
• Support batch manufacture, including line sign-off prior to start of batch manufacture and performing 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 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 manage documentation errors, working with personnel to correct them and develop preventive actions to reduce or eliminate recurrences.
• Manage retain samples.
• Conduct sampling and inspection activities.
• Issue documentation for production, including Batch Records and SOPs.