QC Microbiology - Environmental Monitoring, Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire

Employment Type: Contract

Work Location: On site

Pay:  €30 - €35 per hour

Experience: 5+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

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.

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.

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.

Reading & review of EM plates.

Execution of EM PQ of new facility.

Execution of routine EM & water sampling/testing.

Requirements

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 working in an aseptic cleanroom performing environmental monitoring.

Proficient in the use of LIMS & LMES.

Experience in technical writing.

Experience in qualification of cleanrooms.

Technically strong background in microbiology and aseptic manufacturing

Experience in LIMS, Change Control, 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.

Package

Contract role - Hourly rate €30 - €35 per hour

Minimum 12 month contract

Contact

Karen McHugh is the consultant managing this position.

If you are a QC Microbiologist interested in roles based in Dublin , you can contact Karen by e-mail at Karen@jobcontax.com Karen or phone 353 1 9696683 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of QC Microbiologists in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individuals

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