- JN -022023-1924824
- Mar 21, 2023
I have an excellent new role with a company in Tipperary who are seeking an in process quality assurance specialist to join their growing team. This is a permanent role with shift work.
This person will provide quality support to production activities. You will have minimum 2 years' experience working in a Pharmaceutical GMP industry preferably coming from an accredited HPRA or FDA environment. A 3rd level education in science, engineering or a related discipline is also essential.
Support to batch manufacture including line sign-off prior to start of batch manufacture, 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 of 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.
Monitoring of 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.
Management of retain samples.
Sampling and inspection activities.
Issuance of documentation for production - Batch Record, SOPs.
If this role is of interest, please 'apply now' or contact me on 021 2300 300 or at
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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