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Quality Assurance Associate – Lonza

The Lonza currently have an opportunity within the Quality Assurance Group for a Reviewer conducting the QA review of batch and control records. The role will involve detailed review of completed batch records for compliance to internal policies, procedures and to GMP and to facilitate the close out resulting follow up actions. Full training will be provided for each manufacturing process step and candidate will ultimately review the entire record. A significant proportion of the working day is spent in the Quality Assurance Office within the manufacturing cleanroom environment. You will also need to forge close links with other departments including Manufacturing, Quality Assurance, QC and Validation to ensure batch records are reviewed and corrected in a timely manner.

Position Requirements:

  • Science Degree or equivalent level of experience
  • Significant work experience gained in a Biotech or Pharmaceutical Industry
  • IT literate – MS Office (advanced) – Word, Explorer, Excel, Outlook
  • Database familiarity with searches / queries and accurate data entry
  • Accurate data entry skills. Attention to detail
  • Excellent communication skills (verbal and written English)
  • Demonstration of reliability, flexibility, motivation and a responsible team-orientated attitude
Employer Lonza
Posted 29-10-2015
Location Slough, Berkshire (GB)
Discipline Life Sciences, Biotechnology
Salary Open
Official Notice

Responsibilities:

  • Detailed review of completed batch records on plant
  • Update related tracking databases and run reports
  • Co-ordination of review and follow-up on corrections of GMP documentation
  • Identify compliance with procedures and regulatory requirements; identify / resolve any necessary amendments
  • Liaise with all departments; communicate information and updates as appropriate
  • Assist in pre-release activities efficiently and effectively in close liaison with QP

If you are interested in this opportunity please apply online via official link. Please ensure that you attach your CV to your profile.

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