Are you a QA Analyst with 4+ years experience working in the pharmaceutical or biotechnology industry including working in aseptic operations, protein formulation, vial and syringe filling?

This is a contract role based in Dun Laoghaire, Dublin

If interested, please forward your CV to karen@jobcontax.com for review or call 353-1-7978720 to discuss in confidence.

QA Analyst - Biotech Incoming Inspection - Dublin

Job Description

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

Contractors have a history of either extending their contract or being offered permanent positions on this site.

You will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.  

You will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components. 

The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, you may be asked to carry out additional work functions to support site continuous improvement activities.

Testing of primary and secondary components for use in the manufacture of aseptic products.

Sampling of Excipients and Drug Substance under Grade C conditions.

Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities

Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

Provide training and advice to staff in relation to testing of components and packaging.

Actively participate in audits and their preparation.

Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation

Write, review and approve Standard Operating Procedures in accordance with site Policies.

Perform all activities in compliance with safety standards and SOPs

Support continuous improvement and Operational Excellence initiatives

Any other tasks/projects assigned as per manager’s request.

Requirements 

Must Pass Eye-Tests required for Visual Inspection

University degree. Engineering or Science related discipline preferred.

Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Excellent written and verbal communication skills

Experience working with dynamic cross-functional teams and proven abilities in decision making

Strong organizational skills, including ability to follow assignments through to completion

Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations

Experience working in aseptic operations, protein formulation, vial and syringe filling.

Package

Contract role. €30- €35 Per Hour

Min 12 month contract

Expectations are to be onsite FIVE days a week and it’ll also be a shift role.

We will have people coming in from 07:00 to 15:00, Monday to Thursday, 07:00 to 14:00 on a Friday.

Late shift is from 14:30 to 10:30 Monday to Thursday, 13:30 to 08:30 on a Friday.

Contact

Karen McHugh is the consultant managing this position.

If you are interested in this role you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 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 QA Analyst roles in Dublin and Ireland.

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