This range is provided by Hobson Prior. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from Hobson Prior
Principal Recruitment Consultant // Head Hunter – Supporting Candidates and Clients in Quality and Engineering within Pharmaceuticals, Biotech and…
Hobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant regulations.
Please note that to be considered for this role you must have the right to work in Ireland.
Responsibilities:
* Prepare and maintain the site validation plan.
* Maintain and archive Validation/Qualification documentation.
* Collaborate with other departments to ensure validation project plans are understood and followed.
* Communicate and provide training on the required validation standard to staff and contractors.
* Review and approve validation, qualification protocols and reports.
* Provide supervision to project-related deviations.
* Assist generation of Process and Q/C Equipment Installation, and Operational and Performance Qualifications.
* Interface with external consultants and partners, suppliers and contractors to ensure successful process and equipment validation.
* Provide Q/A assistance to data integrity compliance activities across the site.
* Assist Regulatory Inspections and third party audits.
* Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents.
Key Skills & Requirements:
* BSC in Science / Engineering.
* Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
* Extensive experience with providing QA technical support and oversight to validation and qualification activities.
* Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies.
* Experience in using risk assessment tools including FMEA.
* Ability to balance needs of the business with the needs of the Regulatory challenges.
* Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously.
For more information, please contact Billy O'Brien.
Apply now
If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
By providing your details and submitting this form you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering, Manufacturing, and Quality Assurance
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Hobson Prior by 2x
Sign in to set job alerts for “Quality Assurance Specialist” roles.
Limerick, County Limerick, Ireland 2 weeks ago
Internal Audit Training & Quality Assurance Specialist
Limerick, County Limerick, Ireland 2 weeks ago
Shannon, County Clare, Ireland 4 weeks ago
Internal Audit Training & Quality Assurance Specialist
Limerick, County Limerick, Ireland 1 week ago
DPEM QA Person in Plant-Drug product external manufacturing (Dublin, Ireland)
Limerick, County Limerick, Ireland 6 days ago
Limerick, County Limerick, Ireland 2 weeks ago
Limerick, County Limerick, Ireland 1 week ago
Principal GMP Data Governance Specialist
Limerick, County Limerick, Ireland 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr