Serialization QA lead

23 Nov 2018
23 Dec 2018
R & D , Biotechnology
Contract Type
Specialist Biotech company in the UK are looking for an experienced Serialization QA Lead to work within the Global Serialisation Programme to ensure high standards of compliance with regulatory requirements and the clients policies systems for the successful implementation and timely completion of the Serialisation project. These include;

* Provide Quality and Compliance oversight to serialisation programme team
* Support manufacturing site quality teams as a SME for serialisation.
* Providing Quality support to the non-manufacturing site Quality Organisations (QA Operations, Quality Systems & Compliance)
* Collaborate with serialisation project team, QA Operations, QA IT, manufacturing and Supply Chain leaders to ensure integration of GxP-related requirements into project deliverables.
* Participate in resolving Quality issues and optimize outcomes, facilitating linkage with internal Quality resources, as appropriate.
* Ensure serialisation compliant procedures are delivered (including elements of Track & Trace, tamper evidence to enable reliable daily operation across the entire supply chain.
* Represent Quality in external audits by regulators/customers and ensure the clients related observations are addressed appropriately and timely.
* Support remedial actions (e.g. CAPA) with operational areas of the business.

I am looking for an experienced QA /Serialization lead who is able to start a project before Christmas.

Please call me or e-mail me for more details

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