JOB TITLE:Quality Assurance Associate DEPARTMENT:Quality REPORTING TO:Head of Quality (UK and Ireland) JOB PURPOSE To manage and execute QA activities during commercial manufacture and product development. To perform tasks to ensure the Larne Site and activities operate in compliance with regulatory requirements and Millicent business objectives. To maintain the Millicent Quality Management System, to ensure that all GxP obligations are met. KEY DUTIES AND RESPONSIBILITIES General Duties Continuously develop and maintain the Millicent Quality Management System Establish and maintain QA documentation for commercial manufacture and R&D projects Participate on project teams, serve as QA project representative ensuring Quality by Design principles are applied and risk assessments are performed Review and approve project and site related documentation to include but not limited to deviations, change controls, manufacturing protocols and records, specifications, clinical trial documentation, clinical supply labels Observe and review development activities may include but not limited to: manufacturing of development batches, testing of materials, process and method validation and tech transfer activities. Ensure oversight of third-party suppliers of materials and services including qualification and on-going monitoring to support development CMC activities and regulatory requirements Provide Quality review and approval for R&D analytical validation activities so that these activities meet the required standards appropriate for the activity and phase of development. Provide input and approval of product specification files Collaborate with commercial sites and external operations to ensure smooth interfaces with other functions and successful technical transfer Provide Quality review of CMC regulatory submissions Participate in the self-inspection and audit programs Provide Quality review and approval for the qualification and validation of equipment and facilities. Other Demonstrate good communication and effective teamwork and collaboration Undertake any other duties, which may be assigned by Senior Management. HUMAN RESOURCE MANAGEMENT Adhere to the Companys policies and procedures. Personnel Spec: Essential Good physical health Science degree Previous experience of working with a recognised quality system Experience of cGMP documentation and report writing Close attention to detail Effective communication skills Good IT skills Ability to work as part of a team and individually Desirable Post graduate qualification relevant to QA role Pharmaceutical experience, particularly in QA activities during product development Experience of the application of quality by design principles and risk assessment to product development Proven ability to work under pressure Working knowledge of electronic QMS Strong interpersonal skills This job description should not be regarded as conclusive or definite. It is a guideline within which the individual job holder works. It is not intended to be rigid or inflexible and may alter as the companys strategic direction changes. Millicent Pharma is not in a position to offer Visa sponsorship - therefore candidates will need to have the legal right to work in the UK Skills: Quality assurance