QA Representative - Co Cork

ICDS RECRUITMENT

Cork

QA Representative - County Cork. Main Purpose and Objectives of Position: • Provide Quality leadership, direction and governance for the specific areas of responsibility. • Manage quality related matters specific to area of responsibility. • Responsible for approving appropriate quality related documents. • Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices & promptly report any safety concerns. • Perform ongoing monitoring that includes: - monitoring of quality systems, - production area time on floor audits, - verification of the effective implementation of key GMP programs and. - review of systems that impact product quality to ensure that they operate in a state of control. • Provide QA ownership for products manufactured in area of responsibility. • Provide coaching and mentoring to operations personnel and to other QA reps on appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion. Key Responsibilities: • Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents. • Review and approval of change controls, observations/deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches. • Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews. • Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary. • Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA’s. • Evaluation and contribution of regulatory information to regulatory documents. • Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in the area of responsibility. • Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures. • Report and escalate critical quality issues to the appropriate level of quality management for final resolution. Interested applicants should have: BSc, MSc, or PhD in Chemistry, Engineering or a related discipline, with a minimum of 2 years relevant experience. Key Attributes. • Excellent attention to detail. • Experience working in cross-functional teams and proven ability in decision making. • Demonstrated ability in critical thinking, data analysis, problem solving and experience in root cause analysis. • Strong organisational skills, including ability to follow assignments through to completion. • Understanding of Data Integrity and its applications. • Self-motivated, positive and ability to work under pressure.

395 days ago