Associate Quality Assurance Specialist (Shift IPT)

Job Description Reporting to the Quality Manager, the Associate Quality Assurance Specialist (Shift IPT) role is critically important to ensure Quality oversight and support for the IPT. You will be responsible for supporting multiple Quality Assurance strategies, systems and processes. The candidate will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs, Health Agency regulations and all other applicable governing regulations.

An expectation as part of the team will be to also drive a Quality culture for the site. You will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. Together, the team will build the future through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. You will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role.

The candidate will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required. Our Quality Assurance group ensures all materials inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements as well as ensuring that all equipment is adequately qualified.

JOB DESCRIPTION & SPECIFIC OBJECTIVES The Quality Assurance Specialist within our company is required to Work a  4 shift pattern role Technical knowledge of sterile manufacturing processes Perform  timely reviews of  batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk Respond quickly to unplanned events, technical issues Operational experience of quality systems in a dynamic manufacturing environment e.g.

SAP, Trackwise, MES Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance Support the spot check/walk-through process of the production lines Involved in customer complaint investigation if required Support the annual product quality reviews if required POSITION RESPONSIBILITIES Provide Quality  support to IPT  production teams to ensure cGMP standards are maintained Understanding of sterile manufacturing operations is preferred Ability to learn and utilize computerized systems for daily performance of tasks Ability to prioritize, manage multiple tasks, and meet deadlines Perform  timely reviews on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the risk.

Liaise with other Department representatives to promote improvements in GMP and Quality standards Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations Foster a culture of continuous improvement by deploying our company's MPS tools and support implementation of Model Area within operations from the start REPORTING STRUCTURE Reports to Quality Lead QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS Technical Sterile filling processes and equipment and support services experience Lean Six Sigma Methodology experience desired Education Degree qualification or equivalent (Science, Engineering, Technical) Experience in Sterile Manufacturing General Good organizational skills and attention to detail Requires good written, verbal and interpersonal commun