GMP QA Officer Covance’s work in developing new pharmaceutical solutions has a positive impact on the lives of millions worldwide and there are several great opportunities for you to be a part of this life-saving work. For our BioPharmaceutical CMC Solutions GMP business at the Covance site in Harrogate we are recruiting for a Quality Assurance Auditor (Level 3) to support compliance with Good Manufacturing Practice (GMP) regulations for contract analytical testing (there is no manufacturing on the Harrogate Covance site). The GMP QA Officer is responsible for supporting the local implementation and operation of the GMP Quality Management System. The role aims to ensure the site remains in a state of GMP compliance by participation in investigations, audits, data reviews, validation projects and the delivery of GMP related training, etc. Job duties are as follows: Reviews and approves site quality documents (SOPs, Policies, etc) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards Supports the supplier qualification programme by participating in third party audits Provides regulatory approval of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to release to the Client Supports the GMP QA internal audit programme by leading, reporting and following up of system, process and facility audits Supports the implementation of the global GMP quality management system, helping to ensure that site specific requirements are addressed locally Monitors and reports on appropriate site metrics and data trends related to the performance of the site quality management system for input into the Management Review Process Participates in projects to ensures facilities, utilities, equipment and computer systems are appropriately validated/ qualified; approval of key validation deliverables Reviews and approves investigations (deviations, OOS, customer complaints, etc) into the cause and resolution of quality defects Facilitates root cause investigations into quality defects Participates to the development and delivery of GMP training Provide advice and guidance and independent review to the site on aspects of quality and GMP compliance Participates as tour guide/note taker during Client and Regulatory Authority inspections Contributes to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations
Typically a Degree in Pharmacy, Chemistry or Biology related discipline or equivalent.
The successful candidate should have significant experience in Pharma/CRO GMP environment Previous experience working as a GMP Auditor In depth knowledge of GMP Awareness of quality systems/standards, e.g. ICHQ10 Excellent communication with negotiation skills Used to trouble shoot and come up with solutions Ability to Interact Effectively with Clients Ability to work with minimal supervision Computer Literate