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Qualified Person (QP)

Blackfield Associates are currently supporting a leading Pharmaceutical organisation in search of a Qualified Person to be based permanently at their site in Wiltshire.

You will be responsible for batch certification, disposition; 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Vol.4/ Annex 16.

You will also ensure products are manufactured to cGMP regulations and that the site complies to procedures/regulatory requirements.

Ideally you will have experience in aseptic and/or sterile manufacturing whilst within a QA role in a highly regulated environment, you will need to be eligible to act as a QP on a UK License, along-side an extensive understanding of the MHRA, EU and FDA regulatory guidelines.

If you are interested in this opportunity, please send your CV to craig@blackfieldassociates.com or call Craig on +442392 322346.



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