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Microbiology QA Technician (Pharmaceutical GMP)

Job description

Looking for a QC Microbiology technician for a pharmaceutical client in Dublin North. This role will insure provision of compliance and Microbiology support to manufacturing cleanrooms, including grade C areas and terminally sterilized products. This includes oversight of contamination control measures and environmental monitoring of cleanrooms; assessment of Microbiology results from the contract testing facility, trending of results, implementing controls based on results of trending results; leading investigations in a timely manner and general QA compliance support to ensure monitoring and testing is completed appropriately & in accordance with procedures.
Assess whether this role would be involved in initial review of sterilization documentation from vendor (this would need QA approval also but knowledge of this person would be valuable in this review also) .
Assess whether this role would be involved in review of cleanroom re-certification as per ISO standards.

Contact

If you are interested in this role apply below. I also have more senior roles within QC, QA, QP, Validation, CQV, and other areas of pharmaceutical, medical device and biologics companies. Send me an email to schedule a confidential chat (014744692) - to andrius at sigmar.ie

What is this Job About:

  • Primary duties and responsibilities of the position are as follows. Other duties may be assigned.
  • Perform the assigned task in accordance with procedural requirements and scheduled timelines. Notify supervisor/other impacted stakeholders if procedural requirements or timelines are not being met.
  • Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
  • Responsible for Contamination Control Strategy and oversight of control processes.
  • Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job responsibilities, regulations and Allergan procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.
  • Work directly with Cleanroom Staff/Teams to ensure that all testing and environmental monitoring is completed as per schedule.
  • Ensure appropriate investigation is performed on out of limit results from monitoring and testing.
  • Ensure timely review of data generated within the team in conjunction with team reviewers.
  • Work in conjunction with the relevant training personnel to ensure that sufficient technicians are proficient in the necessary tasks.
  • Represent the company in regulatory inspections as deemed necessary as a subject matter expert in the field of Microbiology
  • Foster an environment of continuous improvements by identifying and implementing efficiencies and quality improvements.
  • Keeping up to date with industry standards relating to topics in Microbiology.
  • Author documents that ensure cGMP compliance, such as Standard Operating Procedures, investigations, reports and forms.
  • Develop and maintain metrics for trends and key performance indicators.
  • Initiate, facilitate, monitor, trend Change Control, Complaints, Deviations, CAPAs and other Quality System documents as required.
  • Support and adhere to established processes and productivity targets.
  • Observe established escalation process for issues impacting established production-related SLAs (Service Level Agreements) and/or fulfillment of production goals.
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training.
  • Carry out and assist in the on-going training of new and existing cleanroom personnel, as appropriate, including oversight of gowning training methods
  • Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.

What Qualifications are Required for this Job

  • Bachelor’s Degree required. Microbiology or Life Science degree preferred with hands on Microbiology experience.
  • Prior pharmaceutical or quality assurance experience, as well as some microbiology experience preferred but not required.
  • Knowledge of cGMP requirements and practices preferred.
  • Strong analytical skills and knowledge of quality systems.
  • Demonstrated written and verbal communication skills.
  • Good knowledge of microbiology tasks and associated regulatory standards and guidance. Ability to anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry. Assess implications of new regulatory guidance and implement necessary changes as they relate to Micro and aseptics/terminally sterilized products.
  • Ability to articulate clearly when dealing with external bodies
  • Ability to use sound judgment to make effective decisions within appropriate timeframes
  • Proven to be self-directed, self-motivated and ability to prioritise competing priorities

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