Job Title
We are seeking a highly skilled professional to join our Global Supply Quality team in Dublin. This is an excellent opportunity for someone looking to work with a leading multinational organization.
* Act as disposition manager ensuring that batch disposition activities are completed in line with company standards.
* Manage and drive Quality records to closure including deviation records, investigation reports.
* Initiate Quality records for supplier related changes.
* Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed.
* Provide data to the networks to support Quality Management Processes)
* Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
* Take part in operational and quality improvement initiatives, programs, and projects.
* Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
Required Skills and Qualifications
To be successful in this role you will need:
* 4+ years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
* Good working knowledge of SAP.
* Experience in investigations, project management and trending and analysis.
* Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
About the Role
This is an exciting opportunity to join a global supply quality team and contribute to the success of a leading multinational organization.