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  • Job reference: RMS0170116

QA Administrator

  • Sector: Oil & Gas
  • Location: Billingham
  • Job type: Contract
  • Date posted: 03/08/2016
This vacancy has now been filled.

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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:
To ensure that control and review of all GMP documentation is maintained to ensure compliance for the site. To maintain a secure archiving system for all cGMP documentation for the site. The Administrators role is to support the site on a day-to-day basis to ensure documentation is complaint at all times and activities are able take place within required timelines.

1. To provide an efficient service to the site for Scanning / Photocopying / Archiving GMP documentation as required to a very high standard for onward supply to Auditors and Customers.
2. Reconciliation, filing, archiving, and retrieval of all data in a timely manner.
3. Ensure administration databases are up to date.
4. To Control and Issue site GMP documentation, including procedures, batch records, analytical methods, validation documents, process specifications etc, these are formal, controlled, auditable documents which form the basis of data recording for product release.
5. Ensuring that all documentation is in the correct format as defined in current site procedures.
6. To ensure all master copies of GMP documentation both electronic and paper are filed securely and correctly.
7. To control the issue of all paper copies of GMP documentation for site use.
8. To perform or witness destruction of documentation.
9. To operate the process for issuing and tracking GMP documentation including reconciliation after use.
10. To maintain a secure and effective archiving system for the site (this includes both on-site and off-site document storage).


1. Experienced in working with document control/approval systems in a GMP environment.
2. Able to Interact with other departments and personnel across the business, demonstrating good interpersonal skills.
3. Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted at daily Tier 1 meetings to ensure business needs are met.
4. Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills.
5. Experienced in administration and able to effectively work with large volumes of information/documentation. Able to perform data entry tasks to a high degree of accuracy.
6. Able to utilise a methodical approach to tasks, ensuring repetitive activities are completed compliantly in line with approved procedures. Identification and escalation of instances where procedural requirements have not been adhered to.
7. Experience and knowledge of archiving in a regulated environment, understanding the need to maintain full traceability and retention of documentation.
8. Fully IT literate, proficient with standard software packages and able to adapt to new software packages/web based systems.
9. Demonstrates an understanding of team dynamics and can work both as part of a team and independently without direct supervision.
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