In Process Quality Assurance Specialist - Shifts Days/Evenings
This role requires a highly motivated and experienced In Process Quality Assurance Specialist to join our client's team in Cashel, Co Tipperary. The successful candidate will work on a shift pattern, alternating between days and evenings every 2nd week.
The primary responsibility of the In Process Quality Assurance Specialist is to ensure batches are manufactured in compliance with regulatory requirements, company policy, and procedures. Key duties include:
* Supporting batch manufacture by performing line sign-off prior to start and conducting in-process checks during batch manufacture.
* Overseeing batch release on the floor.
* Reviewing documentation such as batch records, logbooks, forms, protocols, reports, COAs, etc., for accuracy, completeness, and compliance to GMP and procedural requirements.
* Reviewing Standard Operation Procedures for manufacturing operations and cleaning.
* Participating in investigations related to manufacturing.
* Preparing Standard Operating Procedures, investigations, reports, and forms as required.
* Performing swab sampling (chemical).
* Conducting process audits and monitoring GMP compliance during production activities.
* Maintaining accurate documentation and identifying errors, working with personnel to correct them and developing preventive actions to reduce recurrences.
* Managing retain samples.
* Sampling and inspection activities.
* Issuing documentation for production – Batch Record, SOPs, etc.
* Supporting Training activities – preparation and execution of on-the-job training.
* Supporting 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 tools.
* Professional certification, such as Six Sigma, CQE, or CQA.
* Experience in a 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:
* Healthcare for Employee & Family.
* 33% Shift Allowance.
* Bonus.
* Pension – 5-5% contribution by Employer.
* 23 days holidays.
* Flextime.