Job Description:
PE Global is currently recruiting for a Senior QA Specialist to support a leading multi-national Pharma client based in Ireland.
This is a contract position that requires NPI and Tech Transfer experience. The successful candidate will provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering.
Main Responsibilities:
* Provide quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs
* Ensure programs, policies, and procedures are robust and in line with regulatory and Amgen expectations
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer, and Qualification/Validation activities
* Support a safe working environment by complying with all pertinent environmental health/safety practices, rules, and regulations
* Quality review/approval of BOMs, MBRs, and recipes
* Write, review, and approve Standard Operating Procedures in accordance with Amgen Policies
Requirements:
* University degree in a Science or Engineering related discipline (preferably)
* 7+ years of relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert
* Understanding of principles of Validation and New Product Introduction
* Experience in change control, non-conformance, corrective, and preventative actions, and validation practices
* Strong organisational, communication, coordination, and meeting facilitation skills