QA Specialist
11 Month Fixed Term contract
Role Functions:
· The QA Specialist will work across the site self-directed work teams and hub to identify and resolve issues in order to allow the site to deliver on our COMMIT culture that supports Quality, EHS, Learning and Continuous improvement. This role will provide Quality Assurance (QA) oversight to qualification/validation, technical transfers, regulatory approvals and commercial operations.
· The QA Specialist will be responsible for oversight of Quality Systems across the site including supporting the Operations, Engineering, MS&T, QC and Plan and Procure teams, ensuring compliance with cGMP and corporate regulations.
· The QA Specialist will be responsible for supporting the Operations, Engineering, MS&T, QC and Plan and Procure teams, ensuring compliance with cGMP and corporate regulations.
· Support the development and coaching of key members of the Quality Assurance Operations and Quality Systems teams to drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
· Liaises with internal partners (e.g. Manufacturing Operations, MS&T, Engineering functions etc) in support of daily operations.
· Ensures clear communication on issues and timely escalation as applicable.
· Drives opportunities for continuous improvement.
Experience, Knowledge and Skills
· At least 9 years’ experience in the biotechnology and/or pharmaceutical industry desirable, (preferably both) or equivalent.
· Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
· Proven record of accomplishments in a regulated industry.
· Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
· Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
· Demonstrated collaboration, negotiation & conflict resolution skills.
· Excellent communication skills (written and oral).
· Must be able to work across a team matrix in order to meet accelerated timelines.
· Demonstrated understanding of continuous quality / process improvement tools.
· Exceptional analytical, problem solving & root-cause analysis skills.
· Ability to multi-task and handle tasks with competing priorities effectively.
· Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
Qualifications
· Degree or post-graduate qualification in Science, Pharmacy or equivalent
If you would like to apply for this role or if you have any questions please feel free to contact me at [email protected] or phone 01-8295817