QA Engineer
ICDS Recruitment
Wicklow
QA Engineer - County Wicklow. This position is being offered as a 12 months' fixed-term contract. Duties and responsibilities; To ensure that all site operations are fully in compliance with current international standards for cGMP. This compliance to be maintained with the implementation of effective SOP's and systems, validation of test methods equipment and processes, cGMP training programs and effective auditing and self inspection programs. Job specifics: • Completion of Customer questionnaires and other miscellaneous queries. • Responding to Customer/Regulatory audits and implementing corrective actions. • Involvement in Customer site audits and preparation of response to findings along with QA Supervisor/ QA Manager. • Conducting both Internal and External cGMP audits. • Lead Quality aspect of new product introduction projects. • Participate in Site Validation activities including Process, Cleaning and Equipment validation. Assisting in creating process documentation to ensure production processing consistent within validated parameters. • Recognize and implement opportunities for continuous improvement. • Preparation of Annual Product Reviews. • Write risk assessments to assess and identify potential risks associated with various manufacturing and facility activities. • Team participant in the review and approval of new suppliers. • Review and approval of batch related documentation and final product release. • Investigation reporting including Process Deviations, OOS, Material Failures and Customer Complaints with minimal guidance using root cause methodology. Assist in identifying root causes and coordinate corrective action to quality issues in the facility. • Operation and maintenance of the Documentation system including Change Control. • Drafting of SOP’s, Monographs and Master Batch Records. • Oversight of Pest Control system. • Drive Operational Excellence and Improvement projects related to Quality. • Develop and maintain metrics systems to provide feedback on Quality performance. Monitor event trends in order to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents. • Provision of training/guidance to junior staff. Interested applicants should have: Degree qualification –Science / Chemistry discipline or equivalent experience with relevant regulatory experience. Previous experience in QC or Equipment/Process/Cleaning Validation or a Quality role, in a regulated FDA Environment. Knowledge of Deviation, CAPA, Audit, Change Control and Customer complaint Trackwise Modules (or similar) and ideally SAP (an adantage. Knowledge of ISO9001:2015. This job originally appeared on RecruitIreland.com.
1898 days ago