Overview
Quality Assurance Specialist Jobs in Dún Laoghaire-Rathdown, Ireland at PE Global
Title: Quality Assurance Specialist
Company: PE Global
Location: Dún Laoghaire-Rathdown, Ireland
PE Global is currently recruiting for a Quality Assurance Specialist Technical Support for a leading multi-national Pharma client based in South Dublin.
This is a contract position.
Role:
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Mgr or Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Key Responsibilities:
- Accountable for Quality oversight of processes and procedures related to Packaging, inspection Process Development, Validation, Engineering, Facilities/Utilities.
- Quality review and approval of Validation and qualification documentation and SOPs to support site validation activities:
- Review of DS & QRAES documents
- Review of validation Plans, Protocols, IOQ, 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.
Requirements:
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of automation / IS projects
- 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to [email protected]
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
