Overview
QC Microbiology Document Reviewer Jobs in Blanchardstown, Fingal, Ireland at Recruitment by Aphex
Title: QC Microbiology Document Reviewer
Company: Recruitment by Aphex
Location: Blanchardstown, Fingal, Ireland
Purpose
The QC Microbiology Document Reviewer is responsible for performing high-quality, timely review of QC laboratory documentation to ensure data integrity, regulatory compliance, and adherence to internal SOPs
The documentation reviewer will assess raw data, analytical results, calculations, instrument printouts, and electronic records for completeness, accuracy, ALCOA+ principles, and traceability; verify that methods and specifications are correctly applied; confirm proper approvals and contemporaneous documentation; and identify, triage, and help resolve discrepancies or errors through deviation and CAPA processes.
The individual will collaborate closely with analysts, to clarify data, drive right-first-time execution, and support batch release and stability program timelines.
The individual must be able to perform routine tasks with a minimum of supervision
Responsibilities
- Ensuring high cGMP, GLP standards are maintained while reviewing and adherence to schedules and targets to meet regulatory and business requirements.
- Represent the Microbiology department in internal and external audits where appropriate.
- Close out of actions/ recommendations identified from both internal and external audits.
- Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
- To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
- Perform technical review of data generated in laboratory, validation protocols and reports.
- Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
- To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
- Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
- To keep management updated on issues arising within the laboratory.
- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
- To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
Requirements
- Minimum of 1 year experience in cGMP Quality environment.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Degree in Microbiology or related science.
- Experience in Data Review in a GMP Quality Environment
