AssureBio have partnered with an exciting Biopharmaceutical organisation who are looking to recruit a Qualified Person (QP).
As a QP, you will be in responsible of performing legal and routine duties related to the review, approval, and certification of licenced and investigational products. Maintain effective quality oversight of internal and external contract manufacturing and testing activities in order to ensure that local and global quality systems/procedures are defined, maintained, and operate effectively in accordance with UK, EU, FDA, and RoW regulatory requirements.
- To perform out the legal and routine duties of a QP in the review, approval, and certification of licenced and investigational products, as defined in article 51 of Directive 2001/83/EC (as amended by Directive 2004/27/EC) and as described in Annex 16 of the EU Guide to GMP.
- To oversee the batch disposition process, which includes batch document review and approval, as well as batch certification file compilation. Make quality assessments on released products subject to temperature excursions and communicate to customers.
- To represent the company to external authorities in liaison with MHRA, FDA, EMEA CAs, and OMCLs on product defect reporting, recall, and inspection related matters.
- To assist in the preparation, review, and approval of technical/quality agreements for suppliers and service providers.
- To conduct internal and external audits in conjunction with QA as deemed required (e.g. for-cause investigations and unscheduled cGMP audits). Support management during third-party audits.
- To advise the Director of Quality Operations on any issues that arise that impact supplier or service provider status, bulk product import into the EU, or final product release for use in the UK/EU and export from the EU.
- Eligible QP (UK qualified, under the Permanent Provisions).
- Relevant experience of UK, EU and FDA cGMP requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment.