Quality Assurance Batch Release Officers (Days)

Quality Control Batch Release Officers (Days)

Our client is a Global leader within an enviable reputation for first class quality well-being products. Due to ongoing site expansion, there is an immediate requirement for QA/QC Batch release Quality Officers to join an expanding team. These are days-based roles up to GBP26k plus package, overtime and bonus.

Ideally, we require candidates with a good background in GMP manufacturing & batch release/review and associated documentation. The main purpose of your role is to review batch records for QP disposition, organising a batch release process. You will be the primary QA contact for batch release.

Day to day activities may include the following:

* Checking and approving Batch Manufacturing records
* Checking updates to documents such as Standard Operating Procedures
* Reviewing and advising on deviations
* Preparation of dossiers for QP approval
* Presence in Production areas to review documentation, perform line clearances and perform QA checks
* Ensure GMP & GDP compliance.
* Prepare validation protocols and reports as well as validation plans
* Coordinate timely release of the batches.
* Ensure batch documentation is obtained & reviewed on timely basis
* Checking and reviewing of Lab data and specifications
* Assisting with internal audits and Client audits

KPIs:

* Sign off documentation to meet QP release dates
* Accurate review of documentation to prevent deviations and customer complaints

Role Requirements:

Experience of working in Pharmaceutical, FMCG, Biotechnology/Medical devices or a clean room manufacturing environment would be ideal. A graduate calibre higher would be preferred but not essential.

Knowledge of sterile, aseptic fill and pack preferred but not essential

Experience of working in document control and quality systems management is essential

GMP experience is strongly preferred