What are the responsibilities and job description for the Quality Engineering Manager position at Global Recruiters of Dublin (GRN Dublin)?
This is a fully ONSITE role, MUST HAVE : 7 years of Sterile Injectable Pharmaceutical experience and have worked with Isolator technology.
Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the facility, utilities, equipment, and computer systems meet cGMP and compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
- Working across functions, to establish the site’s quality system processes related to GMP compliance of the facility, utilities, equipment, and computer systems.
- Ensure the Quality oversight and review of validation and qualification activities for the site is performed including assurance that the appropriate resources, materials, and documentation are utilized, and that work is performed in a compliant and controlled manner.
- Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
- Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
