In Process Quality Assurance Specialist

• 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.

• 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.

• Healthcare for Employee & Family
• 33% Shift Allowance
• Bonus
• Pension 5%-5% contribution by Employer
• 23 days holidays
• Flextime

Cpl Group