Senior Quality Assurance Specialist

Description:

We are currently recruiting a Senior QA Specialist for a Biopharmaceutical Manufacturer in Dublin 15.

Key responsibilities will include:

o Support the Qualified Person with the Batch Certification function

o Prepare and review batch documentation packages for QP release as per SOP requirements

o Liaise with Supply Chain and Quality colleagues to ensure that disposition lead times are consistently met

o Update SOPs, controlled documents i.e. FORMS and OJTs

o Assist in new product introduction activities as required

o Provide training to new team members

o Support the site inspection readiness program for corporate and regulatory inspections

o Identify and make recommendations for improvements to ensure continuous improvement

o Participate in site activities associated with the QMS (e.g. Change Control, Self-Inspections, Quality Agreement updates, Customer Complaints, Product Quality Record Reviews) as required

o Ensure that all work carried out follows the required standards conforming to SOPs, regulatory regulations and guidelines, and Quality Agreements

o Perform additional team tasks as agreed to support effective running of the function

Qualifications and Experience required:

o A degree in science, engineering or related discipline is essential. A minimum of 1-2 years’ experience in pharmaceutical /biopharmaceutical industry

o Experience using data or electronic document management systems (DCA, Trackwise, Infinity, and SAP)

o Strong working knowledge of Microsoft Excel and PowerPoint

o Ability to work on his/her own initiative in addition to working as part of a team

o Good organizational skills and attention to detail

o Ability to handle multiple assignments and changing priorities

o Ability to learn and utilize computerised systems for daily performance of tasks

o Ability to prioritize, manage multiple tasks, and meet deadlines