QA – External Quality

Desired Skills: qa specialist,external quality,batch documentation

PE Global is currently recruiting for a QA Specialist, External Quality Operations on behalf of our client based in Dublin.

This is an initial 12 month initial contract role.

This is what you will do:

The QA specialist for external quality operations supports the QA activities as required by External Quality in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. Intern for external quality performs’ all responsibilities in accordance with company policies, procedures, and regulations.

You will be responsible for:

• Authoring, review and approval of QA-related procedures.
• Review of batch documentation.
• Tracking of quality management system activities including deviations, CAPAs and change controls.
• Perform all job functions in compliance with cGMPs and maintain accurate and legible records.
• Where required, maintain external quality metrics/key performance indicators ensuring site visibility and trending to support continuous improvement activities.
• Documentation review of SOPs, master batch records, policies, standards, validation protocols and reports as required.
• Other activities, as required to support the External Quality team and stakeholders.

You will need to have:

• This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
• The person in this position will receive supervisory direction on all routine and non-routine activities. Routine activities will be unsupervised as training and competency develops. The person in this position must have good organizational skills.
• The position requires the individual to work collaboratively with colleagues, peers and managers.
• A good understanding of the concepts and systems applied to cGMP operations is expected.
• We would prefer for you to have:
• In the progress of completing a B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry , Microbiology or Pharmacy

Interested candidates should submit an updated CV.

Please click the link below to apply, 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***