Biotech QA Specialist – Laboratory Validation Technical Support

Job title:

Biotech QA Specialist – Laboratory Validation Technical Support

Company:

JobContax

Job description

Biotech QA Specialist – Validation Technical Support – Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: Site Based / HybridPay: €50 – €57 per hourExperience: 7+ yearsVisa: EU passport or Stamp 4 visa requiredOur 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.This s a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.Provide overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations.Quality review and approval of Validation documentation and SOPs to support site validation activities:Review of DS & QRAES documentsReview of validation Plans, Protocols, IQ, OQ, PQ and associated validation documentsReview of executed validation documents and reportsSupport a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulationsProvide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.Perform all activities in compliance with safety standards and SOPsRequirementsUniversity degree. Science or Engineering related discipline preferred.Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Information Systems)Looking for a specialist that has experience in validationFamiliar with the QRS, risk assessments, and validation life cycleExperience in the lab would be greatExperience from QA, especially supporting qualification activities in the lab – would be open to candidates with at least 8 months experience only in a lab. For example, if we found someone with eight months in the lab, and the person has worked in other projects and is familiar with the validation life cycle, three to four years in the overall qualification in other systems or other areas, this is the kind of profile we would consider.CSV experience is important to have because the validation work is qualifying the software.Understanding of principles of Validation and New Product IntroductionExperience in change control, non-conformance, corrective and preventative actions, and validation practices.Ability to operate across functional boundaries, both internal and external.Ability to work independently and remotely with minimum direct supervision.Critical thinking skills.Strong organisational, communication, coordination, and meeting facilitation skills.Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-makingPackageContract role – Hourly rate €50 – €57 per hourMinimum 12 month contractWork location: This is a hybrid role, so the preference here is for local candidates or candidates within a commutable distance to the site.The expectation is for the successful candidate to be onsite at least once a week.ContactKaren McHugh is the consultant managing this position.If you are a QA Specialist 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 QA Specialists in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individualstaglife

Expected salary

€50 – 57 per hour

Location

Dublin

Job date

Fri, 17 Jan 2025 23:30:35 GMT

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