Senior Quality Assurance Specialist - Technical Support

Posted 12 May 2022
Job type Contract
DisciplineScience CareersEngineering Careers

Job description

Title: Senior Quality Assurance Specialist - Technical Support

Location: Dun Laoghaire, Dublin

* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory expectations.
* Quality review and approval of Process Development and Validation documentation
o Technical transfer documents
o Validation Protocols, executed validation documents and reports
* 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.

Qualifications and Experience:
* University degree - Science or Engineering related discipline preferred.
* Understanding of principles of Validation and New Product Introduction
* Experience in aseptic manufacturing
* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
* 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.

Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.

As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.