QA Executive - Pharma
An exciting start-up manufacturing site in Tipperary needs an experienced Quality Assurance specialist to work in a QMS role and take responsibility for their supplier and vendor management system. Working in a supportive and collaborative environment you`ll benefit from a competitive salary and there are great progression opportunities. You will be responsible for coordination, implementation, and daily management of documentation distribution and maintenance of quality documents required for the use in manufacturing, testing, and packaging of product. About the Job. Provide Supplier related support to Production, Lab, Quality and Process Engineering in the event of a supplier quality problem occurring on a component/raw material. Ensure investigation of supplier related issues through the issuing and monitoring of supplier investigations and generation of non-conformances. Monitor Supplier corrective and preventative actions Plans (CAPA), change control and maintain an up to date approved suppliers list. Coordination, implementation, and daily management of documentation distribution and maintenance of quality documents required for the use in manufacturing, testing, and packaging of product. Full ownership of Vendor Management/Supplier Qualification. Visit supplier facilities, carrying out Supplier Qualification/Surveillance audits to ensure that suppliers are capable of meeting our quality requirements on a continuous basis. Monitor, report and track to closure audit observations arising from audits. Review validations, test reports and protocols related to Supplier changes. Liaise with suppliers on an ongoing basis via regular contact, periodic audits and other methods to guarantee consistent high quality performance on an ongoing basis. About You: Level 8 Qualification in Quality/Engineering related discipline. Minimum 3+ years in a QA, QMS, Quality/Validation Engineering, or similar role within the Medical Device or Pharmaceutical Industry. Qualified auditor and experienced in Supplier Qualification Auditing and Surveillance Auditing. Excellent technical writing skills and attention to detail. Ability to multi-task and flexibility to accommodate changing priorities. Strong process and regulatory knowledge. Customer service oriented. Strong communicator with the ability to influence. High accountability and ownership. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
70 days ago