Senior Quality Engineer - Validation

This is a hybrid position requiring team members to be onsite 3 days a week. No relocation is provided for this opportunity.  At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?   There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary In this role, you will Report to the NPI Senior Quality Manager or Quality Work Package Manager this role will support NPI projects with key focus and responsibility around the interpretation, application of and compliance to the FDA’s Code of Federal Regulations (QSR’s, and cGMP’s), ISO 13485, agreed specification, validation master plan and customer requirements. This person will provide the company with the technical, and quality resources to manage the quality on selected  NPI projects. In particular to coordinate the necessary activities for ensuring the timely closure of internal/external quality issues / projects, ensure the timely and effective closure of internal/external quality issues and to coach and drive a culture of compliance and continuous improvement. Essential Duties and Responsibilities Program Activities: Reporting on project progress, identifying successes, driving compliance via validation master plan (VMP) / customer specification. Escalated to the Program Manager / Quality Manager as required. Responsible for the introduction of quality requirements of new or transferred products into West. Ensure that programmes are introduced  to West in a manner that is in compliance with the appropriate regulatory requirements, customer specification and consistent with West Quality Management Systems (QMS) The generation of a responsibility assignment index (RACI) and the update of same. Support the suppliers selection process in accordance with West supplier management procedures and that confidentiality disclosure agreements (CDA’s) are in place with service provides as required. Metrology data review and reporting to the team during OQ & PQ. Key quality contact on all quality issues with the customer, host Quality & technical forum’s and face-2-face…