Covance

Senior GMP QA Officer

UK-Harrogate
Job Number
2017-13174
Job Category
Quality Assurance
Position Type
Full-Time

Job Overview

For our BioPhamracuetical CMC Solutions businesses in York/Harrogate we are recruiting for a Senior Quality Assurance Officer to support compliance with Good Manufacturing Practice (GMP). The Senior 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 providing expert advise relating to GMP and by actively participation in investigations, audits, data reviews, validation projects and the delivery of GMP related training, etc. Job duties are as follows:

• Provides regulatory approval of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to release to the Client

• 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 GMP QA internal audit programme by scheduling, planning, 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

• Supports the supplier qualification programme by participating in assessments and leading third party audits

• Participates in projects to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables

• Leads and approves investigations (deviations, OOS, customer complaints, etc) into the cause and resolution of quality defects

• Participates in the development and delivery of GMP training

• Provide advise and guidance and independent review to the site on aspects of quality and GMP compliance

• Deputizes for the GMP QA Manager in Leading the Management Review Process and in hosting Client and Regulatory Authority inspections, coordinating the response to observations and follow-up of corrective actions

• Represents Covance GMP QA at conferences and seminars The successful candidate: • Several years QA/GMP experience in the pharmaceutical or related industry

• In depth knowledge of Good Manufacturing Practice Regulations

• Experience of industry quality systems/standards, e.g. ICHQ10, ISO 9000 • Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving

• Experienced GMP Auditor

• Experience in process improvement

• Customer service orientated, i.e. ability to interact effectively with clients and regulatory authorities • Ability to work unsupervised

• Computer literate

Education / Qualifications

Degree (or equivalent) in Pharmacy, Chemistry, Biology related discipline Relevent postgraduate degree (e.g. MSc) preferred

Experience

The successful candidate: • Several years QA/GMP experience in the pharmaceutical or related industry • In depth knowledge of Good Manufacturing Practice Regulations • Experience of industry quality systems/standards, e.g. ICHQ10 • Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving • Experienced GMP Auditor • Experience in process improvement • Customer service orientated, i.e. ability to interact effectively with clients and regulatory authorities • Ability to work unsupervised • Computer literate

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