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Job Details

Long Term Contract Opportunity - QA Auditor/Officer

Company: Planet Pharma Staffing Limited
Location:
Reference: 13819
Closing Date: 25 Dec 16
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

The chance to join a top tier pharmaceutical company in their biotech department! Long term contract opportunity with standing growth potential.

Requirements:

Position Overview:

The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations. 

Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements. 

  • The Auditor communicates and resolves audit comments with client areas. 
  • Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards. 
  • Issue reports summarizing deficiencies and work with areas to execute remedial action. 
  • Notify appropriate management of inspection result. 
  • Position will receive direction and support. 
  • Batch record review 
  • Managing, supporting, reviewing and approving process related and lab related deviations/events. 

Qualifications:

  • Bachelor's or Master's Degree in Science or Engineering (Analytical Chemistry, Biotechnology preferred).
  • At least 5 years of experience in the pharmaceutical industry within the Quality Operations Department. 
  • Minimum of 3 years of experience with exposure to investigations execution in an FDA related environment with technical expertise and strong Quality Systems background. 
  • Knowledgeable with cGMP's applied to drug product/drug substance and manufacturing is required.
  • Technical knowledge in manufacturing processes and analytical testing techniques. 
  • Effective planning skills. 
  • Excellent interpersonal and communication (oral and written) skills, in English & Dutch.
  • Skills: Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma. 
  • Experience with docuemntation systems and SAP is a preference.

Apply for this job: Long Term Contract Opportunity - QA Auditor/Officer

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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