QA Compliance Specialist

QA Compliance Specialist - 12mth Fixed Term Contract As QA Compliance Specialist you will be responsible for supporting the QA GMP supplier and service provider management processes, regulatory surveillance, the internal audit program, inspection readiness, Client audits and Health Authority inspections, support the provision of the GDP orientation, GMP orientation and GMP refresher training programs, generation of PQR’s, approval of risk assessments, change controls & deviations on behalf of the quality department. As QA Compliance Specialist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. Department Description As QA Compliance Specialist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the Vendor and Auditing QA Team Lead. This role is being offered as a 12mth Fixed Term Contract. Essential Duties and Responsibilities: Support the qualification of new material suppliers and GMP service providers and support the maintenance of the Approved Supplier and Service Provider Lists Participate in auditing of GMP suppliers and GMP service providers from time to time. Act as SAP Key User for material supplier data. Support the review and approval of GMP supplier and service provider changes, including coordinating change control activities with internal and external cross functional teams. Support the resolution of quality deviations and closure of CAPAs. Support the internal audit program, including managing the schedule, conducting the internal audit and maintenance and reporting of metrics relating to internal audits. Participate and follow-up on audits and/or inspections carried out at the site by Regulatory Authorities or Clients. Participate in initiatives and action plans for the development of QA and improvement of GMP compliance. Manage and provide support for the site electronic quality management system (EQMS). Provide site metrics and KPIs as required for the Quality Management System (QMS). Provide support for the Quality Management Review (QMR) as applicable. Review and Approve Risk Assessments, change controls, deviations and complaint investigations and collate PQR’s. Support the site regulatory surveillance. Management of product & material complaints. Execute Mock recall. Assist in preparation and presentation of GMP orientation and refresher training programmes. Perform all duties in accordance with GMP

, SOPs and controlled documents. Will be flexible to take on additional tasks and responsibilities at the discretion of the QA Senior Specialist/QA Senior Manager/ QMS Lead. Will act as a role model for the Quality Assurance function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture Your Profile: The ideal candidate for this position will have the following: Education: A Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be an advantage. Knowledge/Experience: Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Experience in the biotechnology and/or pharmaceutical industry within a Quality role. Candidates from Manufacturing Operations, Validation, Engineering, and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered but knowledge of Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required to be demonstrated. Experience in performing internal audits and risk assessments would be an advantage. Technical Competencies: Required: Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures). Strong knowledge of cGxP requirements and regulations Knowledge of trouble shooting and problem-solving skills, e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc. An Auditor qualification would be an advantage Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Behavioural Competencies Adaptable, able to multi-task and handle tasks with competing priorities effectively to deliver site priorities. Demonstrated organisation and collaboration skills with a teamwork mindset. Excellent communication skills (written and oral). Analytical with demonstrated problem solving & root-cause analysis skills Proactive attitude with good attention to detail Other Requirements There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required. If you would like to know more before you apply? Please visit us at [外部招聘链接已隐藏] WuXi Biologics is an equal opportunities employer.