Senior QC Micro Analyst

Website Ref: TPM04444

Summary:
A Senior QC Micro Analyst is required for a biopharmaceutical company in Athlone. This successful candidate will be responsible as an SME on microbiological product testing and environmental monitoring with responsibility for management of QC quality system records including deviations and laboratory investigations, report writing, generation and presentation of QC metrics and environmental monitoring trends to QC and site leadership. This incumbent will also be responsible for coordinating and completing QC batch review.

Responsibilities:

  • Ensuring high cGMP, GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
  • Supporting and coordinating validation/Qualification of Microbiology test methods.
  • Generation of annual environmental monitoring reports.
  • Lead and participate Quality Risk Assessments relating to the Microbiology.
  • Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation.
  • Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
  • Represent the Microbiology department in internal and external audits where appropriate and be responsible for the completion of actions/ recommendations identified from both internal and external audits.
  • To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
  • To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
  • Investigate out of specification/limit results utilizing Root Cause Analysis tools in conjunction with the Microbiology Laboratory Manager, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
  • Perform technical review of data generated in laboratory, validation protocols and reports.
  • Scheduling of testing, review and authorization of microbial data.
  • To represent the Microbiology laboratory at internal and external meetings.
  • 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 keep management updated on issues arising within the laboratory.
  • Provision of trouble shooting and similar expertise in the resolution of laboratory issues as they arise from time to time utilizing Root Cause analysis tools.
  • Identify and implement initiatives designed to improve the efficiency of the laboratory function/department.

Qualifications & Experience:

  • Degree in Microbiology or related Science.
  • Minimum of 5 years of experience in cGMP Quality environment.
  • A high degree of technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
  • Good knowledge of current regulatory requirements for Microbiology /
  • Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
  • Subject Matter Expert in Method Validation, Endotoxin and Bioburden testing.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.