Quality Control Manager based in Dresden
Plant Pharma is partnered with one of our leading pharmaceutical clients who are seeking to hire a quality assurance specialist based in Carlow.
Key Responsibilities:
* Oversee and guide the introduction of new products, ensuring quality standards.
* Serve as the main contact for quality at the site and with external parties, coordinating Quality working group meetings.
* Contribute as a functional expert in the cross-functional team responsible for product introductions at Carlow.
* Conduct quality reviews and approvals for engineering, validation, automation, and utilities commissioning and qualification.
* Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
* Review documentation for new products, including QC Test Specifications, BOMs, and MES documentation.
* Support timely deviation resolution.
* Ensure compliance with divisional policies, guidelines, and regulatory requirements. Proactively assess site compliance and lead major initiatives for improved operational efficiency. Participate in Plant/Quality committees and collaborate with other functional teams.
Qualifications:
* A Bachelor's degree or higher in a related Science discipline preferred.
* A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
* Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
* Strong report, standards, and policy writing skills.
* Experience with equipment and process validation.
* Familiarity with sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology is desired.
Please click ‘Apply’ or contact Sinead Broderick at Planet Pharma for more information: Sbroderick@planet-Pharma.co.uk
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