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 a minimum of 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.
Responsibilities:
1. Support to batch manufacture including line sign-off prior to the start of batch manufacture, performing in process checks during batch manufacture.
2. Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, and COAs generated to support commercial and development batches for accuracy, completeness, and compliance to GMP and procedural requirements.
3. Review of Standard Operating Procedures for manufacturing operations and cleaning.
4. Participate in any investigation related to manufacturing.
5. Prepare Standard Operating Procedures, investigations, reports, and forms as required.
6. Perform swab sampling (bioburden and chemical).
7. Perform internal and process audits.
8. Monitoring of GMP compliance during production activities.
9. Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
10. Management of retain samples.
11. Sampling and inspection activities.
12. Issuance of documentation for production - Batch Record, SOPs.
If this role is of interest, please 'apply now' or contact me on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
#J-18808-Ljbffr