Quality Assurance Administrator

2 weeks ago

Wigston, United Kingdom Consult Full time

My client is a successful privately-owned, award-winning pharmaceutical company with a 12 month fixed term contract position open for a Quality Assurance Administrator to join their team. They have state of the art facilities and this presents a fantasticopportunity for someone. The purpose of this role is to assist with the administration and maintenance of the quality system in order to demonstrate compliance with current Good Manufacturing Practice and company procedures.

**Responsibilities**:

- Creating new Q-Pulse draft document records such as Standard Operating Procedures (SOPs) and Product Specifications
- Issuing of document numbers for validation documentation
- Activation of new and updated documents on Q-Pulse.
- Logging and tracking of training sheets
- QA review of approved master Batch Manufacturing Recordsand Batch Packaging Records prior to issue.
- Issue of BMRs/ BPRs to manufacturing.
- Updating and maintaining QA Access Databases for master BPRs and validation documents
- Following up overdue document reviews including SOPs and BMRs which are beyond their review date.
- Filing and archiving of documentation and records to on-site and off-site storage locations ensuring documents are appropriately logged before being filed.
- Arranging for documents to be retrieved from archived documents storage.
- Checking of production labels against previously approved master labels
- Monthly review of temperature, cleaning, over pressure and balance logs.
- Assisting Document Controllers with clinical trial labelling/packaging activities
- Quality administration support

**About You**:

- Educated to GSCE grade 4 (or equivalent) in Mathematics and English.
- Experience of working in a highly regulated industry (e.g. Doctors surgery, legal secretary, solicitors, council offices, pharmacy, school etc.)
- Experience of working with electronic QMS’s such as Q-Pulse would be an advantage

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