Salary : €25-€30 per hour
REF Number : 00042266
Consultant : Lucy Stendall
Sector : Pharmaceutical
Discipline : Qa / Validation
CK Group are recruiting for a Senior HPLC QC Analyst to join a global bio-tech company on a contract basis in Dun Laoghaire, near Dublin.
The Senior HPLC QC Analyst will be responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance.
Key responsibilities include :
With a high degree of technical flexibility, work across diverse areas within the lab
Planning and performing routine analyses with efficiency and accuracy.
Planning and performing multiple, complex routine / non-routine methods and procedures and a large variety of assays.
Reporting, evaluating, back-up / archive, trend and approve analytical data.
Troubleshooting, solving problems and communicating with stakeholders.
Initiating and / or implementing changes in controlled documents.
Participating in audits, initiatives, and projects that may be departmental or organizational in scope.
Writing protocols and performing assay validation and equipment qualification / verification.
Introducing new techniques to the lab, including method transfers, reports, validations and protocols.
Evaluating lab practices for compliance and operational excellence improvement on a continuous basis.
Approving lab results
May participate in lab investigations.
May provide technical guidance.
May train others.
May contribute to regulatory filings.
May represent the department / organization on various teams
May interact with outside resources.
To be considered for the role, you should have the following skills, knowledge and experience :
Bachelor's degree in a science discipline.
Previous experience of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
Chemistry experience is preferable
HPLC experience is essential