Job Reference: FRS50591
Job Duration:
Start date: ASAP
Description:
Analytical Validation Scientist - Days Role - County Clare
FRS Recruitment are proud to be recruiting on behalf of an International Biotechnology company in the Mid-West whoare looking to significantly expand their Quality Control Operations. I am looking to speak to an experienced Chemistry Analystwith at least 3 years GMP industry experience. They will be responsible for the validation and technology transfer of established test methods for the analysis of gene therapy products. This is a full-time permanent job with full suite of benefits to include Medical Insurance, Life Assurance, Pension, Yearly Bonus.
Responsibilities:
* Ensure that GMP documentation e.g.CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely.
* Ensure that method transfers and validations are fully executed in compliance with regulatory standards and that all data integrity requirements are met.
* Perform routine assessments of all analytical methods to confirm they are operating as expected.
* Provide Subject Matter Expertise as part of regulatory inspections and site audits.
* Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produced.
* Development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
* Write, review and update SOPs and related documentation for QC, where required.
Desired Skills and Experience:
* BSc Degree in a scientific discipline e.g. Biochemistry, Chemistry.
* Minimum 3 years' experience working in a GMP environment.
* Analytical methodvalidation experience in the pharmaceutical (or other regulated industry) is a must.
* Experience in working with any or numerous of the following methods preferred; qPCR, HPLC, ELISA, CGE.
* Proficiency in a body of information required for the role;e.g. knowledge of EU and FDA regulations, GMP/GLP/GDP, etc.
***Min 3 years GMP Industry experience essential along witha degree qualification in a scientific discipline***
For more details and a full job description on this Analytical Validation Scientist Job in Clare, please apply with an updated CV.
Industry: Science and Research
Salary: €45000- €60000 per annum + DOE
Salary Benefits: DOE
Vacancy Type: Permanent
Job Skills: Method Validation, HPLC, GMP, Gene Therapy, Pharmaceutical Jobs
Contact Name: Eoin Looney
Website: -
Direct Application URL: -