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GMP QA Officer III

Covance 8/30/2018 5:42:37 PM
JOB ID: 23597 Category: Quality Assurance
Harrogate, United Kingdom

   

 

Job Overview

The GMP QA Officer 3 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.

This is a full time position, based in our Harrogate and York offices and would be an ideal role for an Experience d GMP QA professional seeking a fresh challenge and opportunities to expand their role and Experience .

Good verbal and written communication in English required.

The position is primarily office-based. Up to 25% time may be spent inspecting Covance laboratory facilities

Essential Job Duties:
- Provides regulatory approval of study related documentation (i.e. protocols, reports, certificates of analysis, etc.) prior to release to the Client

* Supports the GMP QA internal audit program by leading, reporting and following up of system, process and facility audits
* Reviews and approves site quality documents (SOPs, Policies, etc.) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards
* Approves investigations (deviations, OOS, customer complaints, etc.) into the cause and resolution of quality defects *
* Facilitates root cause investigations/ risk assessments
* Provides advice and guidance and independent review to the site on aspects of quality and GMP compliance
* 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
* Contributes to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations
* Supports the implementation of the global GMP quality management system, helping to ensure that site specific requirements are addressed locally
* Participates in the development and delivery of GMP training
* Participates as tour guide/note taker during Client and Regulatory Authority inspections
* Supports the supplier qualification programme by participating in third party audits

Education / Qualifications

Education:
- A minimum of a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

Experience

Experience :

* A minimum of 5 years operating in a GMP environment; more than 3 years Experience in GMP QA
* In depth knowledge of Good Manufacturing Practice Regulations
* Experience d GMP Auditor
* General awareness of industry quality systems/standards, e.g. ICHQ10
* Good communication, decision making, negotiating, and problem solving skills
* Experience in process improvement
* Customer service orientated, i.e. ability to interact effectively with clients
* Ability to work under minimal supervision
* Computer literate


Position Type: Full-Time

Location: Harrogate, UK - United Kingdom



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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 www.gettinghired.com 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).