QA Officer

Brightwater

Waterford

An expanding Laboratory in Waterford is seeking an experienced QA Officer to maintain and administer their Quality system. An attractive package, work environment and Work/Life balance is on offer to the right candidate. About the Job: • Ensure familiarity with current Regulations and Standards as applicable (GMP, GCP, ISO 9001:2008 ). • Ensure continual improvement via the review of internal processes and the implementation of measures where appropriate. • Assist in the creation of a new Sterility and Microbiological testing facility. • Aid in the production, distribution and review of all Controlled Documentation within the Quality Management System. • Aid in the maintenance of other key quality management system processes, for example: € Incident Management. € Complaints. € CAPA. € Supplier Approval. € Validation protocol, report review and approval. • Aid in the development and maintenance of Q-Pulse (Electronic Quality Management System. • Performing internal audits as per internal audit schedule. Reporting findings to appropriate personnel and monitoring progression of actions to ensure prompt completion through the CAPA system. • Performing end-of-study audits for GCP compliance. • Aid in hosting Client audits or Regulatory inspections and the development of responses to subsequent reports. • Providing training in applicable QA concepts and providing the appropriate quality inductions to new personnel. • Aiding in the completion of supplier quality questionnaires. • Deputising for the QA Manager for archiving responsibilities. Ensuring compliance of the archive with GCP/GLP. • To comply with all quality control procedures to support maintenance of the Quality Management System. • To comply with safe working practices in accordance with Company safety policies. • To participate in the Annual Joint Staff Review process, in accordance with Company Policy. • To perform any other duties as may be reasonably required commensurate with grade and experience. • Attend any training endeavours as appropriate to role or as reasonably requested by Line Manager. About You: Degree in Science or relevant area. 4-5 years of QA/QMS experience in a laboratory or regulated manufacturing environment. For more on the role call Nigel on 021 4221000 or send your CV for consideration . This job originally appeared on RecruitIreland.com.

1984 days ago