Operations Specialist - Quality Assurance Biotechnology Manufacturing Sligo – Permanent I am looking to speak with candidates that have 3 years in QA function coupled with circa 5 years industry for the newly created role of QA Operations. You will have knowledge of batch related documentation and activities related to on-going manufacturing including the completion of root cause investigations, change controls and the implementation of process improvements.
Why you should consider this role? Our client is an expanding biotech site and is going from strength to strength. They are going to go into full scale production soon but right now it would be a great opportunity to gain some exposure to pre-production operations. They offer full training and ongoing development and support for your career. The senior leadership team are very inclusive and feedback from placed candidates working there is that the variety and type of work they are undertaking is very interesting.
Day to day duties: QMS areas of responsibility include Deviation Investigations, Change Control and CAPA management systems; performing Internal Audits; assessing Customer Complaints; Vendor Management and supporting External audits.Review/approval of Manufacturing Batch Records.Assessment/approval of production materials including APIs, excipients, primary and secondary packaging.QA point of contact for Operations providing technical expertise, feedback and guidance for QA and compliance topics/issues including manufacturing, validations, new product introduction and assist in the resolution of issues commensurate with the level of risk.Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.Generate, review, and approve SOP's/other documentation as applicable to your areas of responsibility.Review/approval of Quality Control testing.Ensure schedules for review and approval of GMP/batch related documents are maintained to support batch release, technology transfers and new product introduction project timelines.Ensure application of Quality Risk Management principles as applicable.Act as the QA lead in QA activities in Operations work-streams involving cross-functional, multi-department teams including Operations, Quality Control, Quality Assurance, Engineering, and others.Actively contribute to continuous improvement activities.Reach out to ****** or call me on 087 4671309.
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