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  • Job reference: RMS0107982

QA Administrator

  • Sector: Engineering
  • Location: Billingham
  • Job type: Contract
  • Date posted: 16/04/2012
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The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:
Principal Accountabilities
To control review and issue of all site GMP documentation including procedures batch records analytical methods validation documents process specifications etc. Ensuring also that documentation is written to and in the correct format as defined in current site procedures.
To ensure all master copies of GMP documentation both electronic and paper are filed securely and correctly.
To control the issue of all paper copies of GMP documentation for site use and supervise the destruction of documentation.
To operate the process for issuing and tracking GMP documentation including reconciliation after use.
To maintain a secure and effective archiving system for Billingham site (this includes both on-site and off-site storage facilities).
To provide an efficient service to the QA department scanning/photocopying GMP documentation as required for supply to customers.
To identify possible improvements to the QA documentation systems to maintain continuous improvement.
To collate data as required for departmental and site KPI’s.
Write procedural documents for the QA Document control department.

Special Features
QA Document control is responsible for maintaining control and issue of all GMP documentation for the site. It plays a crucial role in ensuring compliance with Cgmp for the site by maintaining
Full traceability of all documentation and associated changes ensuring version control of documents and that all documentation both master documents and completed documentation such as batch records are retained efficiently and securely in such a way that they can be quickly and easily retrieved as required. This is particularly important in such situations as regulatory audits when retrieval time is key to audit performance.

Essential Skills / Qualifications:
The nature of this role requires that the job holder:
• has experience of working with document control/approval systems in a GMP environment.
• Using the experience and knowledge to identify situations that may arise and interact with departments to schedule workloads to meet the business needs.
• Highlight issues at the daily PDR daily meeting.
• Flexibility in approach to work adapting to the current needs of the department.
• Is a skilled and experienced administrator who can self manage and prioritise varying workloads within tight deadlines.
• Is accurate and methodical in their approach to their work which will enable them to ensure a large number of changes to documents can be made with the minimum number of errors.
• Demonstrates the ability to strictly apply the rules of the GMP and line management to what is a very repetitive task but one which is key to the business.
• Has good organisational and time management skills
• Must be fully IT literate proficient in the
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