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Job Details

GMP QA Officer III (Harrogate, UK)

Company: Covance
Location: UK-Harrogate
Reference: 2018-23597
Closing Date: 31 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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.  

Requirements:

This is a full time position, based in our Harrogate and York offices and would be an ideal role for an experienced 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:

  • A minimum of a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

 

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
  • Experienced 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

 

Apply for this job: GMP QA Officer III (Harrogate, UK)

Contact Information:

Address:  Covance Harrogate
Harrogate

England
Website:  Visit Our Web Site

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