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Job Details

GMP QA Officer 3/ Harrogate, UK

Company: Covance
Location: Harrogate, United Kingdom
Reference: 64843BR
Closing Date: 10 Mar 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

At our Early Development 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).

Requirements:

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.

Job Duties Are As Follows

  • 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
  • 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
  • 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 to the development and delivery of GMP training
  • Provides advise 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

The Successful Candidate Will Possess

  • Significant Experience in Pharma GMP environment
  • Experience as GMP Auditor
  • In depth knowledge of GMP
  • Awareness of quality systems/standards, e.g. ICHQ10
  • Good Communication/ Negotiation/Decision Making/Problem Solving Skills
  • Customer Service Orientated/Ability to Interact Effectively with Clients
  • Experience in process improvement
  • Ability to work with minimal supervision
  • Computer Literate

Education/Qualifications Degree (or equivalent) in Pharmacy, Chemistry, Biology related discipline

Relevent postgraduate degree (e.g. MSc) preferred

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

 

 

Apply for this job: GMP QA Officer 3/ Harrogate, UK

Contact Information:

Address:  Covance Harrogate
Harrogate

England

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