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
Limerick
Limerick
Limerick
Limerick
Dublin
Dublin
Limerick
Limerick
Cork
Limerick
Limerick
Westmeath
Limerick
Galway
Galway
Dublin
Donegal
Wexford
Limerick
Cork
Dublin
Dublin
Dublin
Tipperary
Galway
Galway
Dublin
Dublin
Limerick City
Wexford
Limerick
Dublin
Limerick
Cork
Galway
Galway
Dublin
Galway
Donegal
Limerick
Republic of Ireland
Dublin
Dublin
Cork
Westmeath
Republic of Ireland
Dublin
Cork
Meath
Limerick
Cork
Dublin
Dublin
Cork
Dublin
Dublin
Dublin
Dublin South
Limerick
Limerick City
Cork
Cork
Limerick
Longford
Tipperary
Dublin
Republic of Ireland
Tipperary
Dublin
Dublin
Dublin South
Galway
Westmeath
Republic of Ireland
Wicklow
Dublin
Dublin
Westmeath
Dublin
Limerick
Cork City
Galway
Dublin
Galway
Carlow
Tipperary
Galway
Limerick
Dublin
Waterford
Kerry
Limerick
Limerick
Limerick
Dublin
Dublin
Dublin
Donegal
South East
Cork
Galway
Galway
Dublin
Galway
Dublin
Limerick
Dublin
Dublin
Dublin South
Cork
Dublin
Louth
Republic of Ireland
Dublin
Limerick
Galway
Dublin
Cork
Galway
Dublin
Dublin
Cork
Limerick
Westmeath
Dublin
Tipperary
Republic of Ireland
Tipperary
Limerick
Galway
Dublin
Dublin South
Galway
Limerick
Republic of Ireland
Dublin
Cork
Dublin
Republic of Ireland
Tipperary
Cork
Galway
Dublin
Dublin
Galway City
Galway
Republic of Ireland
Galway
Galway
Limerick
Dublin
Cork
Louth
Galway
Limerick
Limerick
Dublin
Galway
Limerick
Galway
Cork
Galway
Senior Quality Assurance Specialist
| Reference: | JSC00030462 | Location: |
Dublin |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. 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.
Duties
• Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
• Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:
o DS, URS & QRAES documents
o Validation Plans, Protocols, IQ, OQ, PQ and associated documents
o Executed validation documents and reports
• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
• Provide 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.
• Quality review/approval of BOMs, MBRs and recipes.
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Perform all activities in compliance with Amgen safety standards and SOPs
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Education & Experience
• University 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 NPI/ technology transfer / product lifecycle changes.
• Understanding of principles of Validation and New Product Introduction
• Experience 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-making.
If interested in this posting please feel free to contact Jack Caffrey on +353 (0)87 3854921or[email protected]forfurther 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
