SR QA Specialist

Desired Skills: batch release,qa specialist,complaints

PE Global is currently recruiting for a Snr Specialist, QA on behalf of our client based in North Dublin:

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
o Employees are expected to display the Biopharma Behavior’s, which enable them to be successful and perform at their highest level. The Behaviors are Passion, Innovation, Accountability and Speed.

Why should you apply:
o You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
o You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

Interested candidates should submit an updated CV.

To apply, please call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***