Good knowledge on the GAMP, cGMP, FDA and EudraLex guidelines for Pharmaceuticals.
Well versed with quality procedures of Validation life cycle, Change Management, Deviations, CAPA, Vendor assessment and Risk Management.
Experience in creating, reviewing and executing documentation as per GAMP guidelines.
Hands-on experience in validation and Qualification, with a focus on validation of computerized systems in QC laboratories.
Experience in authoring Infrastructure Qualification documents
Experience performing Risk Assessments, experience on Risk based validation approach.
Experience in performing gap analysis on current computer systems to ensure compliance with Part 11 and Annex 11.
Completed 21 CFR Part 11 compliance assessments of laboratory systems.
Support Regulatory inspections and internal and vendor audits.
Perform Periodic System Reviews ensuring that the systems maintain their validated state.
Experience in creation and review of Standard Operating Procedures (SOP’s)