Responsibilities
Qualification and/or validation of all equipment for the new PCR Laboratories
Draw up SOPs and implement testing in strict accordance with these SOP(s) ensuring full GMP regulatory compliance as appropriate.
Perform a variety of molecular biology laboratory experiments, test and procedures including isolation and analysis of DNA and RNA, PCR, Q-PCR, restriction endonuclease digestion agarose gel electrophoresis, etc.
Establishment of Test Method SOPs and validation of methods, where appropriate.
Core Duties:
Complete understanding off all regulatory guidelines.
Executions of Protocols and reports.
Make detailed observations and accurately and precisely record data, summarize data for reports and document all activities
Report results of experiments, test, and procedures and analyze data
Carrying out test method procedures.
Assist the Department Manager and/or Supervisor in addressing all departmental quality documents including audit responses, facility replies and deviation reports.
Assist in laboratory investigations where necessary.
Participate in training as required.
Update current standard operating procedures, if required.
Assist in generation of risk assessments for laboratory and test items as required.
Requirements
BSc or MSc a relevant science discipline (e.g. Molecular Biology)
A minimum of 1 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry is highly desirable.
Experience in molecular biology methods, e.g. PCR and Q-PCR are highly desirable.
Experience in method validation highly desirable.
Knowledge of biosafety classifications and Code of Practice for the Safety, Health and Welfare at Work desirable.
Contact Brenda on 0858723761, brenda.flannery@cpl.ie
