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QC Lead

  • Location: Shanbally, Ringaskiddy , Cork, Ireland
  • Type: Temporary
  • Job #22709

QC Lead

Location: Cork

Employment: 12-month contract

Work Model: Hybrid

Visa sponsorship: No

Would you like to join one of the top 3 Pharma employers in the country and make your CV look even better? Here’s your chance!

Why is this a great role:

  • A 12-month contract will give you stability and there is also a potential to convert to permanent in the future!
  • You will join a friendly team of 4-5 so you will have many people to help you and support you if needed
  • You will work hybrid with 3 days from the office and 2 days from home so you can take the best out of both worlds.
  • A short interview process with only 2 stages. We will not waste your time!

What will you do:

  • Coordinate effective planning and execution of projects related to Microbiological methods/ Technology
  • Ensure timelines are managed effectively
  • Ensure consistent delivery to stakeholders and effective communications
  • Provide Technical expertise to QC and external teams
  • Assist in trouble shooting and optimisation of methods
  • Coach and develop individuals within the team
  • Responsible for overall performance of the team in areas of technical delivery and inter-team and inter-department collaboration
  • Collaboration with QC leads to ensure the overall running of the QC Laboratory
  • Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents
  • Ensure the team is compliant to GXP and safety and environmental standards
  • Conduct and document out of specification / out of trend result investigations
  • Develop and Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
  • Lead and implement initiatives that add value to the QC and site operations
  • Deliver on capital/budget
  • Scope out future efficiencies/ optimization opportunities

As Site Microbiologist

  • Coordinate effective planning and execution of projects related to Microbiological methods/ Technology
  • Ensure timelines are managed effectively
  • Ensure consistent delivery to stakeholders and effective communications and provide technical expertise to QC and external teams
  • Assist in trouble shooting and optimisation of methods
  • Responsible for overall performance of the team in areas of technical delivery and inter-team and inter-department collaboration
  • Collaboration with QC leads to ensure the overall running of the QC Laboratory
  • Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents
  • Ensure the team is compliant to GXP and safety and environmental standards
  • Conduct and document out of specification / out of trend result investigations
  • Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
  • Deliver on capital/budget & scope out future efficiencies/ optimization opportunities
  • Establishment of Environmental Monitoring Program sample locations on site and support ongoing review of environmental data and trend results.
  • During development and expansion of the facility, plan for and lead in collaboration with project and support functions the set up and qualification of clean utilities, environmental monitoring programs and where necessary sterilizing equipment.
  • Contamination Control Strategy
  • Act as a Subject Matter Expert in Deviations, Change Controls and in Regulatory Inspections as necessary.
  • Key contributor of out-of-specification/out-of-trend result investigations.
  • Interpret and apply applicable Annex 1, Annex 2, 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives

What will make you successful:

  • 3- 5 years of experience in a QC Analytical Technical role in Pharmaceutical/Biotechnology or medical device industry
  • Expertise in regulatory submissions and health authority interactions (e.g. audits).
  • Understanding of relevant regulations and guidelines e.g., Eudralex Volume 4 Annex 
  • Experience reviewing routine testing results, preparing protocols and reports, performing OOT and deviation investigations.  
  • Strong writing and editing skills for technical documentation.
  • Familiarity with change control software’s such as Trackwise or Veeva QMS etc., Microsoft office applications & analytical software’s such as Empower, chromeleon etc.

    Nice to have: 

  • BSc, MSc. or PHD in Microbiology or similar is desirable.
  • Ideally experience in project management with direct or indirect leadership is desirable.

SUBMIT YOUR CV TODAY!

Everyone will get a response

Please do not hesitate to contact any of our team with any questions you may have on Email: [email protected] or Phone: +353 1 6694040.

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