This is a 12-month contract with a strong view to extension. It is a hybrid position but candidates need to be commutable to the site.
Quality Assurance Specialist - QA Technical Support
Purpose
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.
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 Company 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 company 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.
Requirements
* 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 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 environment.
Skills:
Technical Support, Validation, NPI, Quality Assurance
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