Quality Assurance Packaging Specialist
We are seeking a Quality Assurance Packaging Specialist to ensure the highest standards of quality in pharmaceutical packaging operations.
Main Responsibilities:
* Monitor production processes to guarantee compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs) and company quality standards.
* Perform Acceptable Quality Level Inspections on the Packaging Line.
* Execute QA Release of packaging components and maintain accurate records.
* Generate and manage packaging-related documentation, including Certificate of Compliance Forms and Barcode Issuance Forms.
* Compile Lot Release Packs and maintain an organized filing system for GMP documentation.
Requirements:
* A degree or 3rd level qualification in Science or Quality is required.
* Minimum 1 year of experience in a Quality function within the pharmaceutical or biotechnology industry.
* Strong knowledge of FDA/EMEA regulations and quality systems.
* Excellent organizational and problem-solving skills.
* Proficiency in Microsoft Office suite, especially Excel, Word and PowerPoint.
* Experience in lot release file preparation and in-process inspections for Secondary Packaging processes would be advantageous.
* Familiarity with Lean/Continuous Improvement practices and root cause analysis.