QA Representative (Small Molecule Operations)
QA Representative (Small Molecule Operations) - 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 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. Reports and escalates 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. You should have: 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. Self-motivated, positive and ability to work under pressure. Demonstrate flexibility and adaptability to meet business needs. Excellent interpersonal and communication skills (written and oral. Demonstrate a continuous improvement mind-set.
39 days ago