QA Lead Specialist
WHAT WILL YOU DO?
• Act as a technical compliance expert ensuring the site operates to the applicable cGMP and international standards for our customers on a daily basis.
• Act as a key member in the effective transfer of NPIs in collaboration with the site cross-functional team to provide expert compliance information, with ability to support multiple projects at a given time and ensure timely completion of actions. Manage any identified risks.
• Interact with customers through Quality-to-Quality and cross-functional forums to discuss, transfer of products as well as on-going status of campaigns including investigations and changes as required. Ensure that customer requests such are completed according to agreed timelines.
• Proactively identify risks, issues and best practices within the Quality management System on an on-going basis. Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system. Champion continuous improvement with particular focus on right first time and lean methodologies
• Lead customer audits and be a key participant in regulatory audits.
• Understand new and updated regulations and guidelines as they apply to the business, complete impact assessments and implement actions as required to the site quality management system
• Research complex compliance related questions and provide recommendations based on research and manage implementation.
• Lead and/or contribute site cross-functional project teams as required.
The lead QA specialist will be required to work independently on his/her own initiative as much as working as part of a team to implement improvements in the quality system, As such excellent interaction, communication and presentation skills are necessary to be successful in the role. The Lead QA specialist will be committed to continuous improvement, leading initiatives and working with members of the Value Stream to drive efficiencies and to assure compliance standards for the site.
The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 8-10 years pharmaceutical experience ideally in a QA role. The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task, with ability to work in a fast paced environment.