QA Audit Specialist - CAPA's - Biopharma - Italy

Sicili'  ‐ Onsite
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Description

World leading Biopharmaceutical plant has a contract requirement for an experienced QA / Auditor to work on a large site wide remediation project.



This remediation project has arisen due to an FDA Warning letter, hence the project needs to be assessed and brought back on track, prior to auditing. You will be required to carry out and lead an internal QA Audit, identifying CAPAs and working with teams to complete and close out and action on CAPA's identified.



This will involve working closely with the various teams and work streams.

  

Duties will involve:-



Conduct Internal Audits collaboratively and individually



- Mentor site colleagues on audit process (good practice)

- Ensure audit issue CAPA closure

- Capture and report metrics

- Lead Work Stream on Internal Audits



The management would love to see an Italian speaker, however will consider an English speaker.



To be successful for this role we are looking for candidates with a minimum of 6 years Pharmaceutical experience with the following skillset:

* Pharmaceutical

* Auditing

* QA within a Pharmaceutical evironment

* CAPA's (Correcting Action Preventativite Action) Identifying and close out

* Excellent communication skills to work with various teams

* Aseptic or Sterile experience

* Willing to work in Sicily for the next 6 months +

  

All inclusive rate will be required to include all travel and accommodation.
Start date
n.a
From
Quanta Consultancy Services
Published at
04.04.2016
Contact person:
Lee Mitchell
Project ID:
1103469
Contract type
Permanent
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