Senior QA Manager (R&D)
Brightwater
Waterford
A leading employer in the South East requires an experienced Quality professional for a key role managing the Quality Assurance activities for its manufacturing and R&D sites. Overview. Responsible for quality aspects and support for Inhalation Product Development activities. QA support for multiple sites for the purpose of Device Development activities. Plays a key role in quality management; maintain the quality systems at both sites and ensure compliance with relevant EMA, FDA and other GMP regulations, as well as with corporate policies and standards, in support of GMP manufacturing and testing for Inhalation products. QA oversight of vendors supporting development and manufacture of Inhalation products. The position includes management of the QA team located at a US site. Responsibilities. Final batch release of clinical batches, including review and approval of batch manufacturing records, packaging records, COAs and associated documentation. Review and approval of specifications and other relevant CMC documents. Review and approval of validation protocols and reports. QA oversight of laboratory activities including review of analytical data, protocols and reports. Review and approval of change control for changes to systems including facilities, utilities, equipment, laboratory instruments, test methods, raw material, intermediate and finished product. Review and approval of investigations, deviation reports, and CAPAs. Education / Experience. Professional education in relevant discipline (minimum Bachelor’s degree from an accredited Institute in a scientific field, preferably Chemistry. Master’s degree or PhD preferred. Experience in a pharmaceutical company. Experience in GMP QA. Experience in Inhalation products an advantage. Managerial experience and capabilities. Capable of operating globally. Willingness to travel when necessary. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2436 days ago