In Process QA Specialist (Contract – 12 months)
Optimize Recruitment are partnering with a generics pharmaceutical client with a global dimension in Tipperary to recruit an In Process QA Specialist to support their production activities for a 12 month contract.
This role is partnering with a team of two other IPQA’s and the salary is circa €40K DOE.
- 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, etc.
- Review of Standard Operation Procedures for manufacturing operations and cleaning
- Prepare Standard Operating Procedures, investigations, reports and forms as required
- Perform swab sampling (bioburden and chemical)
- Perform environmental monitoring
- Monitoring of GMP compliance during production activities
- Sampling and inspection activities.
- Issuance of documentation for production – Batch Record, SOPs
- Support training activities – preparation / execution of on the job training
- Support during regulatory/customer/corporate audits as required
Education & Experience:
- Appropriate QA exposure within a GMP pharmaceutical facility
- HPRA and FDA exposure
- Strong attentional to detail with an ability to influence and motivate others
For more information and to discuss similar opportunities, please contact Lee in the strictest of confidence on 0858072559 / firstname.lastname@example.org
Please note your CV will never be released without your expressed permission.