Description: PE Global is currently recruiting for a Senior QA Specialist on behalf of a leading biotech company based in Dublin South.
This is an initial 12-month contract role.
Overview: The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Key Responsibilities: Provide overall quality direction and oversight for key functional areas (i.e.
Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and expectations.
Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents Review of executed validation documents and reports 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.
Perform all activities in compliance with 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 and 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 key functional areas (i.e.
Packaging, Validation, Quality Control, Engineering, Information Systems) Understanding of principles of Validation and New Product Introduction Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
Ability to work independently and remotely with minimum direct supervision.
Strong organisational, communication, coordination, and meeting facilitation skills.
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, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application.
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Skills: quality assurance validation GMP compliance FDA