Senior QA Specialist systems

12 Jan 2018
13 Feb 2018
Contract Type
Full Time
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life.Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?

Job Description Summary

We have a great opportunity for an experienced Senior QA Specialist to join our QA Quality System Group, which is part of our Quality Assurance Department. This role will be based out of our state-of-the-art Slough facility.

As a Sr. QA Specialist (Quality Systems) your primary role will be the responsibility for the Lonza Slough Quality system, the policies and procedures that govern quality at the Lonza Slough site, and ensuring the policies and procedures are simple, effective and efficient.

Keys Responsibilities: Provides QA ownership and oversight of the Lonza Slough Pharmaceutical Quality System (PQS)Ensure PQS is designed to meet site requirements and is comprehensively implemented and incorporates GMP and Quality Risk Management.Ensure GROUP PQS is implemented on site and the on-going generation and maintenance of SOPs and controlled documents.Embed Quality Risk Management on site.Enable site operations performance by managing and supporting GMP issues through the Pharmaceutical Quality System and site governance mechanisms.Supporting Senior QA leadership to drive continuous improvement and ‘fitness for purpose’.Ensure PQS is designed to meet Regulatory, Customer and GROUP requirements and is effectively implemented on siteUtilise knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective, efficient, simple and compliantMonitor and interpret quality metrics and ongoing quality trends to provide information to the site to ensure action is taken in a timely manner to address trends, issue highlighted etc.Actively develop, mentor, train and enforce a site GMP culture within OperationsSupport regulatory and customer audits of the Operations areas and processesIdentify opportunities for GMP compliance training and awareness campaigns – design, develop and deliverInterested? What we need you to have: BSc in Science discipline (or equivalent experience); Qualification in Quality would be an advantageUnderstanding and application of Quality Risk ManagementSignificant industry experience within quality and QASignificant experience in the design, implementation and ongoing management of Pharmaceutical Quality Management SystemExperience of working on and / or run continuous improvement projects on a company wide basis would be an advantageLine management or supervisory experience (preferred)Familiarity with TrackWise and DocumentumStrong computer skills - IT literate - MS Office – Word, Explorer, Excel, Access, OutlookDatabase familiarity with data entry/searches / queriesGood communication skills (verbal and written)

Lonza. The place to Go, Stay and Grow.