In Process Quality Assurance Specialist- Shifts Days/Evenings
On behalf of our Pharmaceutical Client in Cashel, Co Tipperary, we are currently sourcing for a In Process Quality Assurance Specialist with experience in the Pharmaceutical industry to join their team.
This position requires employee to work on a shift pattern. Current pattern is days and evenings every 2nd week – 7-3 or 3-11
The In Process Quality Assurance Specialist to Production activities including batch record review, in process checks, sampling, documentation review and process audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures.
Essential Duties and Responsibilities include,
- Support to batch manufacture including line sign-off prior to start of batch manufacture, performing in process checks during batch manufacture.
- Oversee batch release on the floor.
- Perform routine review of documentation such as Batch records, logbooks, forms, protocols, reports, COAs, etc. 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 investigations related to manufacturing.
- Prepare Standard Operating Procedures, investigations, reports and forms as required.
- Perform swab sampling (chemical)
- Perform 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.
- Issuing documentation for production – Batch Record, SOPs etc.
- Support Training activities – preparation / execution of on-the-job training
- Support the Head of Quality/Designee during regulatory/customer/corporate audits as required.
Education & Experience:
- Minimum 3 years of QA experience.
- Deep knowledge of quality assurance terminology, methods, and tool
- Professional certification, such as Six Sigma, CQE, or CQA
- Experience on Pharmaceutical GMP environment accredited with HPRA and FDA
- Proficiency in best practices for testing, version control, and defect management
- In-depth knowledge of quality management system (QMS) procedures.
- Outstanding problem-solving and decision-making skills.
Benefits Include:
- Healthcare for Employee & Family
- 33% Shift Allowance
- Bonus
- Pension 5%-5% contribution by Employer
- 23 days holidays
- Flextime
If this job sounds ideal to you can Apply please click the Apply Now link.
If you would like to enquire in complete confidence contact Darren Brown on 087 405 3774 or email your details to [email protected]
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