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Recruitment Consultant - Quality Assurance and Validation - Pharma & Biotech
Job Title: QA Compliance Specialist
Location: Ireland
Job Summary:
The biologics facility is looking for a dedicated and detail-oriented QA Compliance Specialist to ensure that all products meet the standards required for marketed and investigational drug products. The ideal candidate will provide quality and compliance oversight, assist in the operations function, and help maintain compliance with all site policies and procedures.
Key Responsibilities:
* Ensure products and aseptic process simulations meet the requirements of end users, regulatory authorities, and the company.
* Provide quality and compliance oversight and assistance to the Operations function.
* Lead and assist in investigations arising from product or manufacturing process non-compliance.
* Review and audit completed Batch Records and Manufacturing Logs.
* Perform quality reviews of operations documentation such as SOPs, JSTMs, and Risk Assessments.
* Conduct Incoming Raw Material checks and maintain product status as required.
* Provide support for the Stability Program, including sample pulls, weekly checks, and protocol generation.
* Administer Quality Logs including QA Hold and Sample Requests.
* Lead daily walk-arounds of manufacturing areas to ensure compliance.
* Drive continuous improvement and simplify site processes and procedures.
* Support other duties as assigned.
Education and Experience:
* A third level degree in a science, quality, or engineering discipline is essential.
* A minimum of three years’ experience in a quality/operations role within a highly regulated GMP environment is required.
* Experience in biologics manufacturing and aseptic processing is highly desirable.
* Strong knowledge of regulatory requirements is essential.
How to Apply:
If you are passionate about quality assurance and compliance and meet the requirements, please submit your CV or email me directly at a.waller@realstaffing.com.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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