Micro QC Analyst / Documentation Analyst

Job Overview

QC Analyst Micro/Documentation Analyst

Office based with one other to support a backlog in batch record review. This is expected to take 6 months, after which time the role requirements will be reviewed and may move into the lab depending on business needs. There will be a high admin focus to the role initially but also the opportunity to get involved in project support outside of the lab.

Responsibilities:

* Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.

* Rapid turnaround of samples to meet manufacturing needs.

* Performing data review and approval.

* Providing support and advice to manufacturing on QC related topics.

* Initiating and leading investigations where required.

* Initiates and completes, CAPAs and Change Controls in accordance with site procedure

* Writes new and updates current procedures on electronic documentation system.

* Proactively identifies and implements lab process improvements.

* Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.

Qualifications & Experience:

* A third level qualification of a scientific/technical discipline is required.

* 1-2 years experience within the Pharmaceutical Industry

* Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.

* Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise

Contact Emer on 0860437889 for more information or a confidential discussion on the role!

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