Senior QA Specialist

ORION GROUP

DUBLIN

Orion Group Sciences have an exciting opportunity for a Senior QA Specialist for our multinational pharmaceutical client based in the South of Dublin area on a 12-month contract. Main Responsibilities of the role. 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. Act as Quality point of contact and decision maker during New Packaging Product Introduction. Technology Transfer and Process Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations. 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. Write, review and approve Standard Operating Procedures in accordance with client Policies. Quality Assurance Tech Support Team responsible for: 1) NPI - Lifestyle management changes: New product into the site team support throughout the lifecycle. Engineering, PPQs to filing. 2) Provide support for bigger projects significant site project changes to the manufacturing areas, cleaning validation, validation supporting automation. 3) IS upgrades, involved with this PSC, MES system get involved through validation of these activities. 4) provide QC team, utility, new fridge freezer equipment etc. **NOTE THIS ROLE IS FOCUSES ON PACKAGING** Desired Experience and Background of the successful candidate. University degree. Science or Engineering related discipline preferred. Relevant experience (5yrs ) 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, 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. 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. #pharmaceutical #pharma #multinational #product #NPI #packaging #engineering #validation #quality #biotechnology #InformationSystems. For more information on this role, call George McGlone on 353212063414 or email George.McGlone@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 929632. Our role in supporting diversity and inclusion. As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

1546 days ago