Ref No: AM17906
County Cork, Republic of Ireland
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.
• 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.
• 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.