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GMP Quality Assurance Officer II

Covance 2/8/2019 2:29:47 PM
JOB ID: 27825 Category: Quality Assurance
Harrogate, United Kingdom



Job Overview

We are recruiting for our Chemistry Solutions team in Harrogate and York and are currently seeking to hire a Quality Officer II to support the team.

This is a full time position, based in our Harrogate or York offices.

About the Job

Within this position, your duties will include:

* Review and approve departmental quality documents (SOPs, Policies, etc.) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards
* Perform regulatory review of study related documentation (i.e. protocols, reports, certificates of analysis, etc.)
* Support the GMP QA internal audit programme by participating in audits of GMP-related systems, processes and facilities
* Review of metrology methods and specifications for accuracy/relevance and compliance with appropriate quality standards
* Approve deviation investigations and CAPA (addressing the cause and resolution of quality defects)
* Supports root cause investigations/ risk assessments
* Participate in projects providing recommendations to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified
* Monitor the effectiveness of the GMP Quality Management System and provide trend data for input into the Management Review Process
* Contribute to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations

Education / Qualifications

To be successful in this position, you will need to hold a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline


Additionally, you will need to demonstrate:

* Some years of Experience operating in a GMP environment or in a non-GMP Quality Assurance role within the Pharmaceutical Industry anda minimum of 1 year in a GMP Quality Assurance role within the Pharmaceutical Industry
* In depth knowledge of Good Manufacturing Practice Regulations
* General awareness of industry quality systems/standards, e.g. ICHQ10
* Good communication, decision making, negotiating, and problem solving skills
* Experience d Auditor
* Experience in process improvement preferable
* Ability to work under minimal supervision

Computer literate

Position Type: Full-Time

Location: Harrogate, UK - United Kingdom


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).