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Job Details

Quality Officer/ Batch review - Oss

Company: Planet Pharma Staffing Limited
Location: Oss
Reference: FLQAMDL
Closing Date: 30 Dec 16
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Department: Quality Assurance Location: Oss, The Netherlands Contract length: 1 year FTE: 1.0 FTE – 40 hours per week (this is not flexible)

Requirements:

Department: Quality Assurance

Location: Oss, The Netherlands

Contract length: 1 year

FTE: 1.0 FTE – 40 hours per week (this is not flexible)

Overview:

·         Seeking 2 Quality Officers for the Quality department at biotech in Oss.

·         These people work on batch record review and management, review and approval of documents related to defects, related both process and lab.

Furthermore, it is important:

Good communication skills
Experience with documentation
Knowledge of FDA audits (because things need to be well documented for FDA audits)
Knowledge of Route Cause Analysis
Good command of NL

Qualifications:

  • Bachelor's or Master's Degree in Science or Engineering (Biotech, Pharmacy, Analytical Technology)
  • 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

Skills:

Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma.

Experience with documentation systems and SAP is preferable 

Apply for this job: Quality Officer/ Batch review - Oss

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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