Edit
Return to Job Search
  • Save This Job
Ref: PECOS04593P

QA Specialist

  • Nationwide / Dublin South / Dublin
  • Negotiable
  • Contract
  • Updated 17/02/2017
  • Catherine O'Sullivan
Apply Now

Description

QA Specialist- Projects

 

PE Global is currently recruiting for QA Specialist for one of our clients in Dublin. Please call Catherine on 0214297900 for more information.

 

Purpose of the role:

 

Providing Quality oversight for Tech Transfer Projects to ensure compliance with regulatory and cGMP requirements during the design, qualification and operational readiness phases for a number of site critical projects. This role is required to partner with relevant departments to ensure that key quality systems are operated and maintained in a compliant manner.

 

Responsibilities of the role:

  • To provide consultative support on quality related issues to project teams.
  • Participate in cross-functional teams as required
  • Ensuring all production steps have been performed and verified, that all limits and specifications have been met
  • QA support for qualification activities - review and approve equipment/utility qualification documentation from design to post execution
  • Review / approval of technology documentation
  • Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production
  • Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required
  • Participate in the internal audit programme as required
  • Maintain tracking system for project document review status
  • Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies
  • Co-ordinate and review change controls as required
  • Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition
  • Review of regulatory documentation
  • Assist in the creation and maintenance of up to date QA policies, SOP’s and reports
  • Assist in the development of training curricula and records for the QA Operations Group

 

Education/Experience:

  • B.Sc. degree in biology, chemistry or equivalent
  • 4 years experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role
  •  1 year experience in a lead role desirable

 

If you are interested in this position, please forward your CV to or call 0214297900

PE Global

PE Global

 

View Agency Profile

View More Vacancies from PE Global

Email me jobs similar to: QA Specialist

Please enter your email address

Similar Jobs

We use cookies to customise our website for you, giving you the best possible user experience. If you continue without changing your settings, we’ll assume that you are happy to receive this personalisation. Find out more about our cookie policy

Accept & Close