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.
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!