Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
 Google Chrome |
 Internet Explorer |
 Mozilla Firefox |
 Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Print this job
Send Job Spec
Share on LinkedIn
Share on Facebook
Share on Twitter
Republic of Ireland
Leitrim
Meath
Carlow
Waterford
Carlow
Galway
Galway
Clare
Dublin
Leitrim
Galway
Galway
Dublin
Carlow
Galway
Dublin
Dublin
North Leinster
Galway
Clare
Longford
Dublin
Dublin
Athlone
Carlow
Tipperary
Dublin
Galway
Dublin
Cork
Connaught
Carlow
Tipperary
Dublin
Leitrim
Tipperary
Galway
Galway
Tipperary
Limerick
Dublin
Dublin
Galway
Athlone
Tipperary
Dublin
Dublin
Galway
Galway
Galway
Tipperary
Westmeath
Galway
Galway
Galway
Carlow
Athlone
Limerick
Athlone
Galway
Athlone
Galway
Clare
Canada
Carlow
Galway
Galway
Dublin North
Galway
Dublin
Dublin
Westmeath
Westmeath
Athlone
Roscommon
Galway
Athlone
Republic of Ireland
Dublin
Dublin
Dublin
Roscommon
Carlow
Dublin
Germany
Clare
Galway
Dublin
Galway
Dublin
Republic of Ireland
Dublin
Dublin
Galway
Dublin
Galway
Dublin
Wexford
Dublin
Dublin
Carlow
Galway
Republic of Ireland
Dublin
Athlone
Dublin
Galway
Dublin
Dublin
Dublin
Dublin
Dublin
Dublin
Dublin
Galway
Limerick
Dublin
Galway
Wexford
Dublin
Cork
Galway
Dublin
Galway
Dublin South
Dublin
Galway
Dublin
Dublin
Galway
Cavan
Dublin
Athlone
Carlow
Carlow
Carlow
Meath
Dublin
Dublin
Clare
Galway
Clare
Connaught
Republic of Ireland
Dublin
Dublin
Athlone
Athlone
Republic of Ireland
Clare
Galway
Connaught
Clare
Dublin
Galway
Limerick
Galway
Leitrim
Galway
Dublin
Galway
Cavan
Galway
Galway
Carlow
Dublin
Dublin
Carlow
Dublin
Galway
Galway
Athlone
Dublin
Dublin
Galway
Galway
Dublin
Galway
Galway
Limerick City
Dublin
Carlow
Dublin
Clare
Galway
Dublin
Meath
Galway
Galway
Carlow
Galway
Dublin
Dublin
Galway
Galway
Dublin
Clare
Tipperary
Limerick
Athlone
Dublin
Dublin
Meath
Galway
Galway
Dublin
Galway
Galway
Dublin
Athlone
Galway
Galway
Connaught
Galway
Galway
Dublin South
Galway
Leitrim
Carlow
Dublin South
Dublin
Galway
Dublin
Galway
Athlone
Galway
Athlone
Dublin
Galway
Clare
Galway
Dublin
Galway
Galway
Dublin
Galway
Dublin City Centre
Limerick
Dublin
Dublin
Limerick
Carlow
Carlow
Dublin
North Leinster
Connaught
Carlow
Roscommon
Dublin
Republic of Ireland
Dublin
Meath
Dublin
Limerick
Leitrim
Republic of Ireland
Cork
Tipperary
Galway
Wexford
Galway
North Leinster
North Leinster
Clare
Dublin
Galway
Dublin
Canada
Dublin
Republic of Ireland
Dublin South
QA Operations Specialist (hybrid)
| Reference: | RK23040 | Location: |
Meath |
| Qualification: | Degree | Experience: | 7-9 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
QA Operations Specialist (hybrid)
RK23040
Contract – 11 months
Meath
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
This role involves being a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. The role will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The Quality Assurance Operations Specialist will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required
Duties:
• Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
• Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
• Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release.
• Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
• Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
• Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Assist in the execution of the internal audit programme including the performance of audits are required.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
• Ensures the escalation of compliance risks to management in a timely manner.
Educational and Experience
• Degree qualification (Science/Quality/Technical).
• 8-10 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
• Project Manager capability with significant understanding of Operations.
• Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
• Experience in quality management systems such as Veeva, SAP, PAS-X etc.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
