Fantastic permanent opportunity for QC Analyst in a new pharma Lab in Cork.
Duties and Responsibilities:
- Participates in authoring procedures for the use of analytical equipment and to describe laboratory ways of working. Participates in suitable training where required to adopt new practices.
- Review standard operating procedures (SOP's), laboratory methods, control of substances hazardous to health (COSHH) assessments, laboratory investigational reports, validation protocols, Risk assessments, reports & protocols.
- Routine Quality Control (QC) testing in accordance with registered methods and current Good Manufacturing Practice.
- Investigative testing in support of root cause investigations for issues that arise within the Supply Chain
- Analytical method development, validation and transfer to support product lifecycle improvement activities across the Supply Chain
- Following validated or experimental analytical procedures and is capable of performing complex laboratory analysis of APIs, raw materials and excipient.
- Analyses data and records data/results in adherence with the client’s SOP's.
- Takes a role in batch/job approval process. As part of this, is responsible for verifying the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria as per relevant SOP's, customer acceptance criteria, methodology, protocol and product specifications.
- Maintaining an up to date training record whilst identifying requirements for further training as required to support areas of responsibility.
- Ensures analytical knowledge and access to systems is up to date for all relevant equipment and techniques and will seek refresher training as required.
- Works on long term objectives to deliver specific improvements or embed changes within the laboratory. Takes ownership of project from concept to delivery, providing progress updates throughout lifetime of project.
- BSc in Chemistry or a related discipline is required.
- A minimum of 1-4 years’ relevant experience in a regulated laboratory.
- Has experience of the analysis of APIs, raw materials and excipients and the associated analytical techniques that may include chromatographic (HPLC, GC, IC), spectroscopic (IR, LC-MS, ICP-OES, Atomic Absorption), physical properties (particle size analysis) and/or pharmacopoeial testing.
For a confidential discussion and more information on the role, please contact Rory Walsh.