Quality Assurance Specialist (Senior) 2
JobTitle: Quality Assurance Specialist (Senior) 28522A About Company: Our client based in Dun Laoghaire is seeking aQuality Assurance Specialist (Senior) 28522A to join its expanding team. Duration of Role: 12 months Summary Objective: • Provide Subject Matter Expertise in relation to the testing of primary and packaging components for use in the manufacture of aseptic products. • Approve IQA Incoming test results. • Manage the introduction of new techniques and equipment to QA Incoming, including method transfers, and validations. Job Duties: • Provide Subject Matter Expertise in relation to the testing of primary and packaging components for use in the manufacture of aseptic products. • Approve IQA Incoming test results. • Manage the introduction of new techniques and equipment to QA Incoming, including method transfers, and validations. • Write protocols and perform validation and equipment qualification/verification. • Assume ownership and/or oversight of change control and NC/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely. • Compile and Analyse Metrics related to testing and disposition times for IQA. • Generate Acceptance Sampling Plans to Justify acceptability of products. • Compile Technical Reports. • Participate in customer complaint investigations with suppliers of components and packaging. • Provide training and advice to staff in relation to testing of components. • Actively participate in audits and their preparation. • Evaluate practices for compliance and operational excellence improvement on a continuous basis. • Act as a designee for the Supplier Quality Management role and Sr. Management role within the group. Requirements. Skills & Experience no visa processing • University degree. Engineering or Science related discipline preferred. • Relevant experience (8yrs ) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications and Experience. • Excellent written and verbal communication skills. • Experience working with dynamic cross-functional teams and proven abilities in decision making. • Project management or strong organizational skills, including ability to follow assignments through to completion. This job originally appeared on RecruitIreland.com.
191 days ago