Company Profile:
Cpl are partnered with a multinational biopharmaceutical organization based in West Dublin. They are seeking to hire for a Senior QA Compliance Specialist on a 6-month contract based in highly modernized workspace with plenty of cutting edge equipment. Well suited to those looking to enhance their overall development within Quality as it would supporting supplier quality operations.
If interested in knowing more or would like to apply please reach or apply below.
Key Responsibilities:
* Review and approve quality agreements.
* Release incoming materials for use in manufacturing operations
* Support qualification of new suppliers/materials and requalification of existing.
* Assess supplier change notifications for impact to qualification status.
* Support material certification and direct dispense programs.
* Review and approve quality agreements.
* Authoring, review and approval of QA-related procedures.
* Support OpEx programs and champion continuous quality improvement initiatives.
* QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
* Change controls
* Deviations/Investigations
* CAPAs
* Other associated documentation
Essential Qualifications:
* BSc in Science or related discipline with a minimum of 2 years’ Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
* A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
* Detailed knowledge of Biologics Processing would be a distinct advantage.
* Required to work on his/her own initiative in addition to working as part of a team.
* Excellent communication, presentation, time-management and organizational skills are essential.
* Employees are expected to display the company behaviors, which enable them to be successful and perform at their highest level.
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