Plant and Technical QA NPI/LCM

10 hours ago

Dublin, Ireland PE Global Full time

PE Global is currently recruiting for a Senior QA Specialist for a leading multi-national Pharma client based in Dun Laoghaire. This is a contract position. Role: Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations. Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities. DS, URS & QRAES documents Validation Plans, Protocols, IQ, OQ, PQ and associated documents Executed validation documents and reports Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations Provide Quality direction and input at Change Control Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Quality review/approval of BOMs, MBRs and recipes. Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. Perform all activities in compliance with Amgen safety standards and SOPs. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role Requirements: University degree. Science or Engineering related discipline preferred. Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes. Understanding of principles of Validation and New Product Introduction Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Ability to operate across functional boundaries, both internal and external. Ability to work independently and remotely with minimum direct supervision. Critical thinking skills. Strong organisational, communication, coordination, and meeting facilitation skills. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: QA Specialist Technology Transfer NPI

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