Quality Assurance DS Release Specialist

ref. 01135

Quality Assurance DS Release Specialist

Location: Dundalk
Type: Contract
Duration: Initially 6 Month (with potential for extension)

Role

Supporting the Qualified Person (QP), the QA DS Release Specialist will be involved in ensuring the timely and efficient release of biological drug substance batches, including preparation and review of batch disposition documentation.

Responsibilities
• Compile deviations, QC data, change controls and batch production record reports to support batch disposition.
• May be required to review batch production records, including liaising with other QA teams or other departments, such as Manufacturing Operations, to resolve any discrepancies noted during the review.
• Provide Annual Product Quality Review(s) (APQRs) and stability data to QPs to support batch disposition activities.
• Support the investigation of quality related deviations and execution of CAPA and related documents.
• Prepare and review SOPs relating to QA DS Release activities, as required.
• Collate batch disposition metrics and KPIs to monitor batch disposition process performance.
• Identify avenues for continuous improvement to ensure batch disposition processes are efficient and to maintain a consistent state of compliance.
• May be required to provide support QPs, including ensuring that registers are maintained up-to-date and checking that tasks as required.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Will be flexible to take on additional tasks and responsibilities.

Technical Skills
• Strong knowledge of cGxP requirements and regulations
• Strong technical aptitude (i.e. capable to read & comprehend technical documentation & execute procedures).
• Troubleshooting and problem-solving skills, e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc.
• Demonstrated knowledge of Quality Management System and continuous process improvement tools.

Requirements
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools
• A Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be an advantage.
• Analytical, problem solving & root-cause analysis skills
• Must be willing to travel when required. There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs.
• There may be a requirement for direct reports to work shift pattern once the project phase is complete.
• Excellent communication skills (written and oral).

Experience
• Experience in the biotechnology and/or pharmaceutical industry within a Quality role, preferably in Operations support or similar.
• Candidates from Manufacturing Operations, Validation, Engineering and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered but knowledge of Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required to be demonstrated.
• Experience in reviewing batch manufacturing and QC documentation is an advantage
• Experience in writing and/or reviewing Deviations, Change Controls, CAPAs and APQRs is an advantage.