Quality , Science, Pharmaceutical & Food

QC Micro – South Dublin – Days

  • Contract
  • Remote
  • Dublin South
  • 41969321

PE Global are currently recruiting for a Sr QC Micro Analyst for a client site in South Dublin  –

QC Micro – Snr Associate, Days Role.


This role will support qualification of a new production facility by writing qualification documents, SOPs, trend reports etc. The current expectation is to work days, however there may be a request to go on shift at a later date in order to support performance qualification of the new facility.


Specific Job Duties:

  • Lead QC Technical documentation projects as an individual contributor.
  • Accountable for timely completion of projects within the technical writing role.
  • Collaborate with internal resources and business partners to support project requirements and ensure project completion.
  • Work in accordance with cGMP and GLP requirements.
  • Ensure consistent and good documentation practices are followed.
  • Creation, review, and update of documentation, e.g. Laboratory Technical Protocols and Reports, Standard Operating Procedures, and Analytical Protocols.
  • Translating complex topics into clear, concise, and understandable topics is required.
  • Review standards for documentation types, structure, and assembly so that content is organised logically with the end reader in mind.
  • Maintain Documents in the document management system.

Additional tasks:

  • Support QC Specialist with risk assessments/procedures for new facility
  • Working with the project team to ensure we have sufficient resources and equipment for the project
  • Completing qualification works for the new isolator, media qualification etc
  • Reading & review of EM plates
  • Execution of EM PQ of new facility


Basic Qualifications

  • Bachelors degree in a science discipline
  • Biopharmaceutical QC experience in Environmental Monitoring
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Experience in technical writing

Preferred Qualifications

  • Experience working in an aseptic cleanroom
  • Proficient in the use of LIMS & LMES


  • Technically strong background in microbiology and aseptic manufacturing
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
  • Flexibility – the EM role often encounters changing priorities on a daily basis
  • Good cross functional communication skills are essential
  • Presentation skills
  • Problem solving skills
  • Experience with Regulatory inspectors and interacting with inspectors desirable
  • Demonstrated ability to work independently and deliver right first time results
  • Works under minimal direction
  • Work is guided by objectives of the department or assignment
  • Follows procedures
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments.
  • Recognizes and escalates problems
  • Demonstrated leadership and communication skills
  • Auditing documentation and operation process
  • Demonstrated ability to interact with regulatory agencies


Interested candidates should send their CV to mailtoAudrey.mccarthy@peglobal.net or call 0214297900

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