QA Technician
ICDS Recruitment
Wicklow
QA Technician- County Wicklow. This position is being offered on a one-year contract basis. PURPOSE OF THE POSITION. 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. ESSENTIAL JOB FUNCTIONS: • Review and approval of batch related documentation and final product release. • Investigation reporting including Process Deviations, OOS, Material Failures and Customer Complaints. • Preparation of Annual Product Reviews. • Operation and maintenance of the Documentation system including Change Control. • Assist in Customer site audits. • Maintenance of Training Records and update of Training Matrix. • Team participant in the review and approval of new suppliers. • Monitor and action Pest Control and temperature monitoring system on a rotational basis. • Conducting internal cGMP audits and tracking completion of corrective actions. • Provide quality related training to others. • Develop and maintain metrics systems to provide feedback on Quality performance. • Participate in Site Validation activities including Process, Cleaning and Equipment validation. • Drafting of SOP’s, Monographs and Master Batch Records. • Completion of Customer questionnaires and other miscellaneous queries. • Participate in new product introduction projects. QUALIFICATIONS and EXPERIENCE SOUGHT: Essential: Certificate Qualification in Science/Chemistry/Engineering discipline. Desirable: Degree Qualification in Science / Chemistry discipline or equivalent experience with relevant regulatory experience. Experience: Ideally previous experience in a Quality role, in a regulated environment. Proficiency in Microsoft Packages and database systems. Excellent oral and written communication skills. Attention to detail and good organisational skills. Mature judgment, problem solving and decision-making ability. Ability to operate in a team based environment. Desirable: Experience in Regulatory Affairs. This job originally appeared on RecruitIreland.com.
2227 days ago