Job Description
The QA Senior Regulatory Chemist will report to the QA Regulatory Manager, you will have a particular focus on analytical activities and associated systems such as Sample Manager, reviews with an emphasis on ensuring regulatory compliance, streamlining and providing innovation solutions to these systems
Responsibilities
Coordinate /review regulatory submissions and provide responses to Health Authorities questions related to new and port-approval CMC fillings with strong emphasis on analytical
Support specification setting for new products.
Assess Compendia changes to methods and specifications associated with standards for impact.
Setting and updating alert limits and their management on Sample Manager.
Support change control activities mainly associated with testing standards and test methods and assess change controls for regulatory impact ensuring compliance in relation to analytical validation protocols and reports.
Support regulatory inspections on site
Education & Qualifications
Degree level qualification with 5 years experience in the pharmaceutical industry.
Strong analytical (including Sample Manager),regulatory and GMP background
A flexible and highly organised.
Strong interpersonal skills and attention to details are required
The ability to make decisions and consistently meet the deadlines necessary in a manufacturing environment.
Project Management experience
For further information on this QA Senior Regulatory Chemist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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