Join to apply for the Quality Assurance Administrator role at Inizio Engage.
Our client has an excellent opportunity for an Administrator to join their Quality Assurance team, reporting to a Principal Quality Officer. The purpose of this role is to assist with the administration and maintenance of the company's Quality Management System in order to demonstrate compliance with current Good Manufacturing Practice and company procedures.
This entry-level Quality Assurance Administrator role is well-suited to recent graduates with a science based degree or individuals starting their career.
The role will involve:
- Issuing of reference numbers for SOPs, QC codes, validation protocols, etc.
- Activation and control of new and updated documents on Q-Pulse, including Standard Operating Procedures (5OPs), Chemistry documentation (PSs, TMs), Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs).
- Follow up of review of documents including SOPs, VMPs and BMRs/BPRs which are beyond their review date on Q-Pulse.
- Updating and maintaining QA documents database - Reviewing and reconciliation of record sheets (1156/C and 1156/D) also Access database for BPRs and validation documents
- QA review of approved Batch Manufacturing Records (BMR) and Batch Packaging Records prior to issue.
- Issue of BMRs/ BPRs to manufacturing.
- Checking of production labels against previously approved master labels
- Monthly review of production logs.
- Filing and archiving of documentation and records to on-site and off-site storage locations.
- Arranging lor documents to be retrieved from archived documents storage.
- Management of archived materials. Ensuring documents are appropriately logged before being filed.
- Assisting Document Controllers with clinical trial labelling/packaging activities
- Quality administration support for other departments.
The ideal candidate will have the following experience and abilities:
- 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.) - not essential
- Competent use of Microsoft Office applications (e.g. Excel, Access and Word).
- Experience of working with electronic QMS's such as QPulse - not essential
Benefits include:
- Daily travel allowance
- Pension
Seniority level
Employment type
Job function
Industries
- Administrative and Support Services and Office Administration
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