Amgen Plant Quality Assurance Manager (Shift) in Dublin, Ireland
Plant Quality Assurance Manager
The Plant QA Manager is a senior role within PQA and reports directly to PQA Senior Manager. The PQA Manager will be responsible for leading and directing Quality staff, will be a Subject Matter Expert in their assigned area of responsibility and also required to understand and grasp a broad range of quality related competencies. Please note this is a 24/7 shift role.
Plant QA Manager Responsibilities:
• Responsible for leading and directing Quality staff including managing their performance and supporting their development.
• Provide real-time QA oversight and support for production operations. This currently extends to formulation, Vial and Syringe Fill Finish aseptic operations.
• Collaborate with Operations to resolve quality and compliance issues, including but not limited to Change Controls, Deviations and CAPAs.
• Ensures that changes that could potentially impact product quality are assessed according to procedures (e.g. site change control, Maximo)
• Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
• Alerts senior management of quality, compliance, supply and safety risks
• Support and represent Quality during audits and inspections
• Support Lean Transformation and Operational Excellence initiatives
• Provides training and advice to staff in order for them to perform their desired functions.
The knowledge and skills necessary to perform the duties of the QA Manager are typically acquired through the following combination of education, experience and knowledge.
• University degree - Engineering or Science related discipline preferred.
• Relevant experience (8 years +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• Technical skills and demonstrated competencies across a broad range of quality related disciplines.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Experience in management or leadership roles
• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
• Excellent written and verbal communication skills
• Strong organizational skills, including ability to follow assignments through to completion
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.