Senior QA Technical Support
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | EngineeringQualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2155 |
| Job Views | 114 |
- Description
- Would you like to join a leading biopharmaceutical company at their state-of-the-art site in Dublin?
We have an opening available for a Senior Quality Specialist within Technical Support. This is a senior position within the QA function and you will be a Subject Matter Expert in your assigned area of responsibility. You will also Provide QA support and supervise a range of technical projects, including New Product introduction to Packaging lines, introduction of new manufacturing equipment
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Provide QA support and oversight for a range of technical projects, including New Product introduction to Packaging lines, introduction of new manufacturing equipment (ex: new packaging line, new AVI, new vessels, freezers, etc..), IS, Computerized Systems & Automation projects (ex: BMS, PCS, FMS, HMI upgrades etc..)
Quality review and approval of qualification/validation documentation
Review of Risk Assessments, DS, URS & QRAES documents
Review of validation Plans, Protocols, FAT, SAT, IQ, OQ, PQ and associated validation documents
Review of executed validation documents and reports
Perform all activities in compliance with Amgen safety standards and SOPs
Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
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.
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
What you need to apply:
Bachelor’s degree in science, or an Engineering related discipline is ideal.
7+ years of relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as Clean Utilities project
Independent and self-motivated.
Critical thinking skills.
Strong organisational, communication, coordination, and meeting facilitation skills.
